| Primary | Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | Safety Analysis Set: all participants who received any ABBV-951 infusion | Posted | | Count of Participants | | Participants | No | From first dose of study drug until 30 days following last dose of study drug (up to 480 days) | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
| | | Title | Denominators | Categories |
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| Any TEAE | | | | TESAE | | |
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| Primary | Number of Participants With Adverse Events of Special Interest | Treatment emergent adverse events of special interest are defined as any adverse event of infusion site infections, infusion site reactions, hallucinations/psychosis, falls and associated injuries, polyneuropathy (peripheral neuropathy), weight loss, or somnolence from the first dose of study drug until 30 days following last dose of study drug. | Safety Analysis Set: all participants who received any ABBV-951 infusion | Posted | | Count of Participants | | Participants | No | From first dose of study drug until 30 days following last dose of study drug (up to 480 days) | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | |
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| Primary | Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale | Skin tolerability was assessed using the Infusion Site Evaluation Scale, a 2-part numeric (0-7) and letter (A-G) grade scale, where a notable skin reaction is defined as a reaction with a numeric grade of 6 or 7 or a letter grade of D, E, F, or G. Any observation of infusion site reaction with irritation criteria > 2 or > C was recorded as an adverse event (AE). | Safety Analysis Set: all participants who received any ABBV-951 infusion | Posted | | Count of Participants | | Participants | No | Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Primary | Hematocrit (Hematology): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | proportion of red blood cells in blood | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Hemoglobin (Hematology): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | g/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | cells*10^12/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | cells*10^9/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Neutrophils (Hematology): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | cells*10^9/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Lymphocytes (Hematology): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | cells*10^9/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Monocytes (Hematology): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | cells*10^9/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Absolute Platelet Count (Hematology): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | cells*10^9/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | picograms | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | g/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | seconds | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | seconds | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Creatinine (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | µmol/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | U/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | µmol/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | U/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | U/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | U/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | U/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | U/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
|
| Primary | Sodium (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
|
| Primary | Potassium (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
|
| Primary | Calcium (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
|
| Primary | Uric Acid (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | µmol/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
|
| Primary | Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Albumin (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | g/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Glucose (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
|
| Primary | Magnesium (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
|
| Primary | Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | mL/sec/1.73m^2 | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Homocysteine (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | µmol/L | | Baseline, Weeks 6, 26, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | nmol/L | | Baseline, Weeks 6, 26, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | pmol/L | | Baseline, Weeks 6, 26, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | -ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | pH (Urinalysis): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | no units | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Specific Gravity (Urinalysis): Change From Baseline to End of Study | Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | No units | | Baseline, Weeks 6, 26, 39, and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | | OG002 | ABBV-951 All Participants | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. |
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| Primary | Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | mmHg | | Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine) | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Primary | Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study | Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | mmHg | | Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine) | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
|
| Primary | Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study | Orthostatic pulse rate was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | beats/minute | | Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine) | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. | |
|
| Primary | Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | beats/minute | | Baseline, Day 1 (postdose), Weeks 6 and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
|
| Primary | Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Day 1 (postdose), Weeks 6 and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
|
| Primary | Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Day 1 (postdose), Weeks 6 and 52 | | | | ID | Title | Description |
|---|
| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Primary | Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Day 1 (postdose), Weeks 6 and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Primary | Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Day 1 (postdose), Weeks 6 and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Primary | Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Day 1 (postdose), Weeks 6 and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Primary | Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study | 12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit. | Safety Analysis Set: all participants who received any ABBV-951 infusion with available data | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Day 1 (postdose), Weeks 6 and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Secondary | Average Daily Normalized "Off" Time: Change From Baseline to End of Study | Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. When "Off" was the first morning symptom upon awakening, this was considered morning akinesia in this study. Baseline value is defined as the average of normalized "Off" time collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement. | Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure | Posted | | Mean | Standard Deviation | hours | | Baseline, Weeks 1, 6, 13, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Secondary | Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study | Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time with troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement. | Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure | Posted | | Mean | Standard Deviation | hours | | Baseline, Weeks 1, 6, 13, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Secondary | Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study | Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Positive changes from Baseline indicate improvement. | Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure | Posted | | Mean | Standard Deviation | hours | | Baseline, Weeks 1, 6, 13, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Secondary | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study | The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part I assesses the participant's non-motor aspects of experiences of daily living (nM-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part I scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement. | Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Secondary | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study | The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part II assesses the participant's motor experiences of daily living (M-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement. | Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Secondary | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study | The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part III assesses the participant's motor examination (including Hoehn and Yahr stage) with 33 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part III scores range from 0 to 132, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement. | Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Secondary | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study | The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part IV assesses the participant's motor complications with 6 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part IV scores range from 0 to 24, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement. | Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup. |
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| Secondary | Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study | The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep grouped into 3 domains: motor symptoms at night (5 items), Parkinson's Disease (PD) symptoms at night (5 items), and disturbed sleep (5 items). The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often] with the exception of Question 1 score ranging from 0 [very often] to 4 [never]). Scores are calculated for each of the 3 domains as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep. Negative changes indicate improvement from Baseline. | Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 6, 13, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 |
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| Secondary | Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study | The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable). Higher scores are consistently associated with more severe symptoms of the disease such as tremors and stiffness. The results can be presented in either domain scores or as a summary index score. The full range of the PDQ-39 summary index score is from 0 (no patient-related symptoms/quality of life unaffected) to 100 (highest patient-related symptoms/low quality of life). Negative changes indicate improvement from Baseline. | Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 6, 13, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 |
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| Secondary | The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study | The EuroQol 5-dimension questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. The health status is converted to an index value using the country-specific weighted scoring algorithm for the United States (US). The summary index value for the US ranges from a worst score of -0.109 to a best score of 1. An increase in the EQ-5D-5L total score indicates improvement. | Full Analysis Set: all participants who received any ABBV-951 infusion and had a Baseline and treatment observation for at least 1 efficacy outcome measure | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 6, 13, 26, 39, and 52 | | | | ID | Title | Description |
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| OG000 | ABBV-951 Low Dose Subgroup | After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup. | | OG001 | ABBV-951 High Dose Subgroup |
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