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This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.
This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.
Subjects will participate for a total of up to 9 weeks, including screening, the 4-week treatment period and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CX-8998 | Experimental | T-type calcium channel blocker |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CX-8998 | Drug | T-type calcium channel blocker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Treatment in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) | Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates. | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Alanine Aminotransferase Serum Chemistry Concentration | Clinical safety laboratory assessment in alanine aminotransferase serum chemistry concentration. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Albumin Serum Chemistry Concentration | Clinical safety laboratory assessment in albumin serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Albumin/Globulin Serum Chemistry Concentration | Clinical safety laboratory assessment in albumin/globulin serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Alkaline Phosphatase Serum Chemistry Concentration | Clinical safety laboratory assessment in alkaline phosphatase serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Aspartate Aminotransferase Serum Chemistry Concentration |
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Inclusion Criteria:
Exclusion Criteria:
History of surgical intervention for treatment of epilepsy.
Additional seizure (clinical and electrographic) types, including, but not limited to, epileptic spasms, generalized tonic seizures, atonic seizures, or focal seizures. Subjects with GTCS or myoclonic seizures are eligible for the study.
Inadequately treated psychotic or mood disorder (e.g., schizophrenia, major depression, bipolar disorder).
Presence of severe intellectual disability, severe autism spectrum disorder, or severe developmental disorder such that the subject cannot sign the ICF or cannot cooperate with the study procedures.
Presence of positive urine drug screen for drugs of abuse, except if this is explained by use of an allowed prescription medicine.
Regular use of more than 2 standard drinks of alcohol per day (28 grams of pure alcohol).
Hypersensitivity/allergic reaction to other T-type calcium agents, such as (but not limited to) ethosuximide and zonisamide.
Use of strong CYP3A4 inhibitors, including prescription or non-prescription drugs or other products (i.e. grapefruit juice), which cannot be discontinued at least 2 weeks prior to Day 1 of dosing and throughout the study (Appendix C).
Concurrent illnesses that would be a contraindication to trial participation, including, but not limited to:
Positive result for HIV, Hepatitis B [indicating ongoing infection], or Hepatitis C at screening or otherwise known ongoing infection with HIV, hepatitis B, or hepatitis C, unless curative therapy completed; for hepatitis C curative therapy is defined as negative PCR for HCV RNA.
Significant hepatic (AST/ALT or bilirubin ≥ 2X upper limit of normal) or renal disease (creatinine clearance ≤39 mL/min) at screening.
History of alcohol or substance abuse within the last year.
A current C-SSRS score of 4 or 5 at screening or history of suicide attempt.
Psychological, social, familial, or geographical reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.
Any other condition and/or situation that causes the Investigator or Study Safety Representative to deem a subject unsuitable for the study (including, but not limited to, expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures).
Treatment with an investigational agent within 30 days prior to the first dose of CX-8998 or planning to receive an investigational agent during the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Epilepsy Program | Little Rock | Arkansas | 72205 | United States | ||
| University of Florida |
Participants underwent a screening period of up to 4 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | CX-8998 | Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics were assessed using the Intent-to-Treat Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | CX-8998 | Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to End of Treatment in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) | Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates. | QTcF was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | msec | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
|
Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks.
Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CX-8998 Days 1 - 2 (4 mg/d) | Participants were administered suvecaltamide orally 2mg capsules twice daily (4 mg/d) on Days 1 to 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure & Transparency | Jazz Pharmaceuticals | 215-832-3750 | ClinicalTrialDisclosure@JazzPharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2019 | Mar 29, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 21, 2020 | Mar 29, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| C562694 | Epilepsy, Idiopathic Generalized |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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Clinical safety laboratory assessment in aspartate aminotransferase serum chemistry. |
| Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline Clinical Blood Urea Nitrogen/Creatinine Serum Chemistry Concentration | Clinical safety laboratory assessment in BUN/Creatinine serum chemistry. | Baseline (Day 1) |
| Change From Baseline to End of Treatment in Clinical Bilirubin Serum Chemistry Concentration | Clinical safety laboratory assessment in bilirubin serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Blood Urea Nitrogen Serum Chemistry Concentration | Clinical safety laboratory assessment in blood urea nitrogen serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Carbon Dioxide Serum Chemistry Concentration | Clinical safety laboratory assessment in carbon dioxide serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Chloride Serum Chemistry Concentration | Clinical safety laboratory assessment in chloride serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Calcium Serum Chemistry Concentration | Clinical safety laboratory assessment in calcium serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Cholesterol Serum Chemistry Concentration | Clinical safety laboratory assessment in cholesterol serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline Clinical Cholesterol/HDL-Cholesterol Serum Chemistry Concentration | Clinical safety laboratory assessment in cholesterol/HDL-cholesterol serum chemistry. | Baseline (Day 1) |
| Change From Baseline to End of Treatment in Clinical Creatine Kinase Serum Chemistry Concentration | Clinical safety laboratory assessment in creatine kinase serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Creatinine Serum Chemistry Concentration | Clinical safety laboratory assessment in creatinine serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Globulin Serum Chemistry Concentration | Clinical safety laboratory assessment in globulin serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline Clinical Glomerular Filtration Rate (GFR) Adjusted for Body Surface Area (BSA) Serum Chemistry Concentration | Clinical safety laboratory assessment in glomerular filtration rate adjusted for BSA chemistry. | Baseline (Day 1) |
| Change From Baseline to End of Treatment in Clinical Estimated Glomerular Filtration Rate (GFR) Serum Chemistry Concentration | Clinical safety laboratory assessment in GFR serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Glucose Serum Chemistry Concentration | Clinical safety laboratory assessment in glucose serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline Clinical HDL Cholesterol Serum Chemistry Concentration | Clinical safety laboratory assessment in HDL cholesterol serum chemistry. | Baseline (Day 1) |
| Baseline Clinical LDL Cholesterol Serum Chemistry Concentration | Clinical safety laboratory assessment in LDL cholesterol serum chemistry. | Baseline (Day 1) |
| Change From Baseline to End of Treatment in Clinical Lactate Dehydrogenase Serum Chemistry Concentration | Clinical safety laboratory assessment in lactate dehydrogenase serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Magnesium Serum Chemistry Concentration | Clinical safety laboratory assessment in magnesium serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline Clinical Non-HDL Cholesterol Serum Chemistry Concentration | Clinical safety laboratory assessment in non-HDL cholesterol serum chemistry. | Baseline (Day 1) |
| Change From Baseline to End of Treatment in Clinical Phosphate Serum Chemistry Concentration | Clinical safety laboratory assessment in phosphate serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Potassium Serum Chemistry Concentration | Clinical safety laboratory assessment in potassium serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Protein Serum Chemistry Concentration | Clinical safety laboratory assessment in protein serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Sodium Serum Chemistry Concentration | Clinical safety laboratory assessment in sodium serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Triglycerides Serum Chemistry Concentration | Clinical safety laboratory assessment in triglycerides serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Clinical Urate Serum Chemistry Concentration | Clinical safety laboratory assessment in urate serum chemistry. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Basophils Hematology Assessment | Clinical safety laboratory basophils hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Basophils/Leukocytes Hematology Assessment | Clinical safety laboratory basophils/leukocytes hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Eosinophils Hematology Assessment | Clinical safety laboratory eosinophils hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Eosinophils/Leukocytes Hematology Assessment | Clinical safety laboratory eosinophils/leukocytes hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Concentration Hematology Assessment | Clinical safety laboratory mean corpuscular HGB concentration hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Hematology Assessment | Clinical safety laboratory mean corpuscular HGB hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Mean Corpuscular Volume Hematology Assessment | Clinical safety laboratory mean corpuscular volume hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Erythrocytes Hematology Assessment | Clinical safety laboratory erythrocytes hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Erythrocytes Distribution Width Hematology Assessment | Clinical safety laboratory erythrocytes distribution width hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Hematocrit Hematology Assessment | Clinical safety laboratory hematocrit hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Hemaglobin Hematology Assessment | Clinical safety laboratory hemaglobin hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Leukocytes Hematology Assessment | Clinical safety laboratory leukocytes hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Lymphocytes Hematology Assessment | Clinical safety laboratory lymphocytes hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Lymphocytes/Leukocytes Hematology Assessment | Clinical safety laboratory lymphocytes/leukocytes hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Mean Platelet Volume Hematology Assessment | Clinical safety laboratory mean platelet volume hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Monocytes Hematology Assessment | Clinical safety laboratory monocytes hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Monocytes/Leukocytes Hematology Assessment | Clinical safety laboratory monocytes/leukocytes hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Neutrophils Hematology Assessment | Clinical safety laboratory neutrophils hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Neutrophils/Leukocytes Hematology Assessment | Clinical safety laboratory neutrophils/leukocytes hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Platelets Hematology Assessment | Clinical safety laboratory platelets hematology assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Bacteria Urinalysis Assessment | Clinical safety laboratory bacteria urinalysis assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Urine Bilirubin Urinalysis Assessment | Clinical safety laboratory urine bilirubin urinalysis assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Epithelial Cells Urinalysis Assessment | Clinical safety laboratory epithelial cells urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-10 epithelial cells/high power field (hpf). A worse outcome is >10 epithelial cells. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Urine Erythrocytes Urinalysis Assessment | Clinical safety laboratory urine erythrocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-2 erythrocytes/high power field (hpf). A better outcome is 0 or "none seen." | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Urine Glucose Urinalysis Assessment | Clinical safety laboratory urine glucose urinalysis assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Ketones Urinalysis Assessment | Clinical safety laboratory ketones urinalysis assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Leukocyte Esterase Urinalysis Assessment | Clinical safety laboratory leukocyte esterase urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is "negative." An abnormal assessment or worse outcome is a positive assessment (i.e., 2+). | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Urine Leukocytes Urinalysis Assessment | Clinical safety laboratory urine leukocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-5 leukocytes/high power field (hpf). An abnormal assessment or worse outcome is >5 leukocytes/hpf (i.e., 11-30). | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Mucous Threads Urinalysis Assessment | Clinical safety laboratory mucous threads urinalysis assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Nitrite Urinalysis Assessment | Clinical safety laboratory nitrite urinalysis assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Occult Blood Urinalysis Assessment | Clinical safety laboratory occult blood urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is "negative." An abnormal assessment or worse outcome is a positive assessment (i.e., 2+). | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Protein Urinalysis Assessment | Clinical safety laboratory protein urinalysis assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Specific Gravity Urinalysis Assessment | Clinical safety laboratory specific gravity urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is 1.005-1.030. An abnormal assessment or worse outcome is a value outside of this range. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment | Clinical safety laboratory specimen appearance urinalysis assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Urobilinogen Urinalysis Assessment | Clinical safety laboratory urobilinogen urinalysis assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in pH Urinalysis Assessment | Clinical safety laboratory pH urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Baseline to End of Treatment in Urine Color Urinalysis Assessment | Clinical safety laboratory urine color urinalysis assessment. | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
| Number (%) of Participants Who Did Not Complete The Study Due to Treatment-Emergent Adverse Events | Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period as assessed by CTCAE v4.0. | Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks. |
| Number (%) of Participants With Adverse Events of Special Interest | An adverse event of special interest is a serious adverse event as defined in Outcome 6. This includes, however is not limited to, increased seizure frequency, new seizure types, worsening of EEG parameters, systemic adverse events based on safety profile as assessed by CTCAE v4.0. | Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks. |
| Change From Baseline to End of Treatment in Respiration Rate | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Temperature | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
| Baseline Weight | Baseline (Day 1) |
| Change From Baseline to End of Treatment in Pulse | The change from baseline to end of treatment in participants' pulses was assessed. The changes in recumbent pulse, standing pulse, and the change from recumbent to standing pulse are reported. Change from recumbent to standing pulse was measured by the difference in recumbent pulse change and standing pulse change. | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Systolic Blood Pressure | The change from baseline to end of treatment in participants' systolic blood pressure (sbp) was assessed. The changes in recumbent sbp, standing sbp, and the change from recumbent to standing sbp are reported. Change from recumbent to standing sbp was measured by the difference in recumbent sbp change and standing sbp change. | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Diastolic Blood Pressure | The change from baseline to end of treatment in participants' diastolic blood pressure (dbp) was assessed. The changes in recumbent dbp, standing dbp, and the change from recumbent to standing dbp are reported. Change from recumbent to standing dbp was measured by the difference in recumbent dbp change and standing dbp change. | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in QT Interval | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in QRS Interval | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in PR Interval | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
| Change From Baseline to End of Treatment in Heart Rate | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
| Tampa |
| Florida |
| 33612 |
| United States |
| Bluegrass Epilepsy Research, LLC | Lexington | Kentucky | 40504 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| NYU Comprehensive Epilepsy Center | New York | New York | 10016 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Change From Baseline to End of Treatment in Clinical Alanine Aminotransferase Serum Chemistry Concentration | Clinical safety laboratory assessment in alanine aminotransferase serum chemistry concentration. | Clinical alanine aminotransferase serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | U/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
|
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| Primary | Change From Baseline to End of Treatment in Clinical Albumin Serum Chemistry Concentration | Clinical safety laboratory assessment in albumin serum chemistry. | Clinical albumin serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | g/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
|
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| Primary | Change From Baseline to End of Treatment in Clinical Albumin/Globulin Serum Chemistry Concentration | Clinical safety laboratory assessment in albumin/globulin serum chemistry. | Clinical albumin/globulin serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
|
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| Primary | Change From Baseline to End of Treatment in Clinical Alkaline Phosphatase Serum Chemistry Concentration | Clinical safety laboratory assessment in alkaline phosphatase serum chemistry. | Clinical alkaline phosphatase serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | U/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Aspartate Aminotransferase Serum Chemistry Concentration | Clinical safety laboratory assessment in aspartate aminotransferase serum chemistry. | Clinical aspartate aminotransferase serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | U/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline Clinical Blood Urea Nitrogen/Creatinine Serum Chemistry Concentration | Clinical safety laboratory assessment in BUN/Creatinine serum chemistry. | Clinical BUN/Creatinine serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) |
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| Primary | Change From Baseline to End of Treatment in Clinical Bilirubin Serum Chemistry Concentration | Clinical safety laboratory assessment in bilirubin serum chemistry. | Clinical bilirubin serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | umol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Blood Urea Nitrogen Serum Chemistry Concentration | Clinical safety laboratory assessment in blood urea nitrogen serum chemistry. | Clinical blood urea nitrogen serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | umol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Carbon Dioxide Serum Chemistry Concentration | Clinical safety laboratory assessment in carbon dioxide serum chemistry. | Clinical carbon dioxide serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Chloride Serum Chemistry Concentration | Clinical safety laboratory assessment in chloride serum chemistry. | Clinical chloride serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Calcium Serum Chemistry Concentration | Clinical safety laboratory assessment in calcium serum chemistry. | Clinical calcium serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Cholesterol Serum Chemistry Concentration | Clinical safety laboratory assessment in cholesterol serum chemistry. | Clinical cholesterol serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline Clinical Cholesterol/HDL-Cholesterol Serum Chemistry Concentration | Clinical safety laboratory assessment in cholesterol/HDL-cholesterol serum chemistry. | Clinical cholesterol/HDL-cholesterol serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) |
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| Primary | Change From Baseline to End of Treatment in Clinical Creatine Kinase Serum Chemistry Concentration | Clinical safety laboratory assessment in creatine kinase serum chemistry. | Clinical creatine kinase serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | U/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Creatinine Serum Chemistry Concentration | Clinical safety laboratory assessment in creatinine serum chemistry. | Clinical creatinine serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | umol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Globulin Serum Chemistry Concentration | Clinical safety laboratory assessment in globulin serum chemistry. | Clinical globulin serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | g/dL | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline Clinical Glomerular Filtration Rate (GFR) Adjusted for Body Surface Area (BSA) Serum Chemistry Concentration | Clinical safety laboratory assessment in glomerular filtration rate adjusted for BSA chemistry. | The clinical glomerular filtration rate adjusted for BSA serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | mL/sec/1.73m^2 | Baseline (Day 1) |
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| Primary | Change From Baseline to End of Treatment in Clinical Estimated Glomerular Filtration Rate (GFR) Serum Chemistry Concentration | Clinical safety laboratory assessment in GFR serum chemistry. | Clinical GFR serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | mL/sec/1.73m^2 | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Glucose Serum Chemistry Concentration | Clinical safety laboratory assessment in glucose serum chemistry. | Clinical glucose serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline Clinical HDL Cholesterol Serum Chemistry Concentration | Clinical safety laboratory assessment in HDL cholesterol serum chemistry. | Clinical HDL-cholesterol serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) |
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| Primary | Baseline Clinical LDL Cholesterol Serum Chemistry Concentration | Clinical safety laboratory assessment in LDL cholesterol serum chemistry. | Clinical LDL-cholesterol serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) |
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| Primary | Change From Baseline to End of Treatment in Clinical Lactate Dehydrogenase Serum Chemistry Concentration | Clinical safety laboratory assessment in lactate dehydrogenase serum chemistry. | Clinical lactate dehydrogenase serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | U/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Magnesium Serum Chemistry Concentration | Clinical safety laboratory assessment in magnesium serum chemistry. | Clinical magnesium serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline Clinical Non-HDL Cholesterol Serum Chemistry Concentration | Clinical safety laboratory assessment in non-HDL cholesterol serum chemistry. | Clinical LDL-cholesterol serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) |
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| Primary | Change From Baseline to End of Treatment in Clinical Phosphate Serum Chemistry Concentration | Clinical safety laboratory assessment in phosphate serum chemistry. | Clinical phosphate serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Potassium Serum Chemistry Concentration | Clinical safety laboratory assessment in potassium serum chemistry. | Clinical potassium serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Protein Serum Chemistry Concentration | Clinical safety laboratory assessment in protein serum chemistry. | Clinical protein serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | g/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Sodium Serum Chemistry Concentration | Clinical safety laboratory assessment in sodium serum chemistry. | Clinical sodium serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Triglycerides Serum Chemistry Concentration | Clinical safety laboratory assessment in triglycerides serum chemistry. | Clinical triglycerides serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Clinical Urate Serum Chemistry Concentration | Clinical safety laboratory assessment in urate serum chemistry. | Clinical urate serum chemistry was assessed using the safety population. | Posted | Mean | Standard Deviation | umol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Basophils Hematology Assessment | Clinical safety laboratory basophils hematology assessment. | Clinical basophils were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | cellsx10E9/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Basophils/Leukocytes Hematology Assessment | Clinical safety laboratory basophils/leukocytes hematology assessment. | Clinical basophils/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Eosinophils Hematology Assessment | Clinical safety laboratory eosinophils hematology assessment. | Clinical eosinophils were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | cellsx10E9/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Eosinophils/Leukocytes Hematology Assessment | Clinical safety laboratory eosinophils/leukocytes hematology assessment. | Clinical eosinophils/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Concentration Hematology Assessment | Clinical safety laboratory mean corpuscular HGB concentration hematology assessment. | Clinical mean corpuscular HGB concentration was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Hematology Assessment | Clinical safety laboratory mean corpuscular HGB hematology assessment. | Clinical mean corpuscular HGB was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | fmol | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Mean Corpuscular Volume Hematology Assessment | Clinical safety laboratory mean corpuscular volume hematology assessment. | Clinical mean corpuscular volume was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | fL | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Erythrocytes Hematology Assessment | Clinical safety laboratory erythrocytes hematology assessment. | Clinical erythrocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | cellsx10E12/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Erythrocytes Distribution Width Hematology Assessment | Clinical safety laboratory erythrocytes distribution width hematology assessment. | Clinical erythrocytes distribution width was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Hematocrit Hematology Assessment | Clinical safety laboratory hematocrit hematology assessment. | Clinical hematocrit was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Hemaglobin Hematology Assessment | Clinical safety laboratory hemaglobin hematology assessment. | Clinical hemoglobin was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | g/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Leukocytes Hematology Assessment | Clinical safety laboratory leukocytes hematology assessment. | Leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | cellsx10E9/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Lymphocytes Hematology Assessment | Clinical safety laboratory lymphocytes hematology assessment. | Lymphocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | cellsx10E9/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Lymphocytes/Leukocytes Hematology Assessment | Clinical safety laboratory lymphocytes/leukocytes hematology assessment. | Lymphocytes/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Mean Platelet Volume Hematology Assessment | Clinical safety laboratory mean platelet volume hematology assessment. | Mean platelet volume was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | fL | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Monocytes Hematology Assessment | Clinical safety laboratory monocytes hematology assessment. | Monocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | cellsx10E9/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Monocytes/Leukocytes Hematology Assessment | Clinical safety laboratory monocytes/leukocytes hematology assessment. | Monocytes/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Neutrophils Hematology Assessment | Clinical safety laboratory neutrophils hematology assessment. | Neutrophils were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | cellsx10E9/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Neutrophils/Leukocytes Hematology Assessment | Clinical safety laboratory neutrophils/leukocytes hematology assessment. | Neutrophils/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Platelets Hematology Assessment | Clinical safety laboratory platelets hematology assessment. | Platelets were assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | cellsx10E9/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Bacteria Urinalysis Assessment | Clinical safety laboratory bacteria urinalysis assessment. | Bacteria urinalysis was assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Urine Bilirubin Urinalysis Assessment | Clinical safety laboratory urine bilirubin urinalysis assessment. | Urine bilirubin was assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Epithelial Cells Urinalysis Assessment | Clinical safety laboratory epithelial cells urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-10 epithelial cells/high power field (hpf). A worse outcome is >10 epithelial cells. | Epithelial cells were assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Urine Erythrocytes Urinalysis Assessment | Clinical safety laboratory urine erythrocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-2 erythrocytes/high power field (hpf). A better outcome is 0 or "none seen." | Urine erythrocytes were assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Urine Glucose Urinalysis Assessment | Clinical safety laboratory urine glucose urinalysis assessment. | Urine glucose were assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Ketones Urinalysis Assessment | Clinical safety laboratory ketones urinalysis assessment. | Ketones were assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Leukocyte Esterase Urinalysis Assessment | Clinical safety laboratory leukocyte esterase urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is "negative." An abnormal assessment or worse outcome is a positive assessment (i.e., 2+). | Leukocyte esterase was assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Urine Leukocytes Urinalysis Assessment | Clinical safety laboratory urine leukocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-5 leukocytes/high power field (hpf). An abnormal assessment or worse outcome is >5 leukocytes/hpf (i.e., 11-30). | Urine leukocytes were assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Mucous Threads Urinalysis Assessment | Clinical safety laboratory mucous threads urinalysis assessment. | Mucous threads were assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Nitrite Urinalysis Assessment | Clinical safety laboratory nitrite urinalysis assessment. | Nitrite was assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Occult Blood Urinalysis Assessment | Clinical safety laboratory occult blood urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is "negative." An abnormal assessment or worse outcome is a positive assessment (i.e., 2+). | Occult blood was assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Protein Urinalysis Assessment | Clinical safety laboratory protein urinalysis assessment. | Protein was assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Specific Gravity Urinalysis Assessment | Clinical safety laboratory specific gravity urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is 1.005-1.030. An abnormal assessment or worse outcome is a value outside of this range. | Specific gravity was assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment | Clinical safety laboratory specimen appearance urinalysis assessment. | Specimen appearance was assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Urobilinogen Urinalysis Assessment | Clinical safety laboratory urobilinogen urinalysis assessment. | Urobilinogen was assessed using the safety population. | Posted | Mean | Standard Deviation | nmol/L | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in pH Urinalysis Assessment | Clinical safety laboratory pH urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. | pH was assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Baseline to End of Treatment in Urine Color Urinalysis Assessment | Clinical safety laboratory urine color urinalysis assessment. | Urine color was assessed using the safety population. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose. |
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| Primary | Number (%) of Participants Who Did Not Complete The Study Due to Treatment-Emergent Adverse Events | Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period as assessed by CTCAE v4.0. | Participants who did not complete the study was assessed using the safety population. The number of participants analyzed varied as participation declined over time. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks. |
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| Primary | Number (%) of Participants With Adverse Events of Special Interest | An adverse event of special interest is a serious adverse event as defined in Outcome 6. This includes, however is not limited to, increased seizure frequency, new seizure types, worsening of EEG parameters, systemic adverse events based on safety profile as assessed by CTCAE v4.0. | Participants with adverse events of special interest were assessed using the safety population. The number of participants analyzed varied as participation declined over time. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks. |
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| Primary | Change From Baseline to End of Treatment in Respiration Rate | Respiration rate was assessed using the safety population. | Posted | Mean | Standard Deviation | breaths/min | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Temperature | Temperature was assessed using the safety population. | Posted | Mean | Standard Deviation | celsius | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
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| Primary | Baseline Weight | Weight was assessed using the safety population. | Posted | Mean | Standard Deviation | kg | Baseline (Day 1) |
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| Primary | Change From Baseline to End of Treatment in Pulse | The change from baseline to end of treatment in participants' pulses was assessed. The changes in recumbent pulse, standing pulse, and the change from recumbent to standing pulse are reported. Change from recumbent to standing pulse was measured by the difference in recumbent pulse change and standing pulse change. | Pulse was assessed using the safety population. | Posted | Mean | Standard Deviation | bpm | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Systolic Blood Pressure | The change from baseline to end of treatment in participants' systolic blood pressure (sbp) was assessed. The changes in recumbent sbp, standing sbp, and the change from recumbent to standing sbp are reported. Change from recumbent to standing sbp was measured by the difference in recumbent sbp change and standing sbp change. | Systolic blood pressure was assessed using the safety population. | Posted | Mean | Standard Deviation | mmHg | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Diastolic Blood Pressure | The change from baseline to end of treatment in participants' diastolic blood pressure (dbp) was assessed. The changes in recumbent dbp, standing dbp, and the change from recumbent to standing dbp are reported. Change from recumbent to standing dbp was measured by the difference in recumbent dbp change and standing dbp change. | Diastolic blood pressure was assessed using the safety population. | Posted | Mean | Standard Deviation | mmHg | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in QT Interval | QT was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | msec | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in QRS Interval | QRS interval was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | msec | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in PR Interval | PR interval was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | msec | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
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| Primary | Change From Baseline to End of Treatment in Heart Rate | Heart rate was assessed using the safety population. The number of participants varied due to the lack of completion of assessments. | Posted | Mean | Standard Deviation | beats/min | Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose. |
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| 0 |
| 7 |
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | CX-8998 Days 3 - 8 (8 mg/d) | Participants were administered suvecaltamide orally 2-2mg capsules twice daily (8 mg/d) on Days 3 to 8. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG002 | CX-8998 Days 9 - 14 (12 mg/d) | Participants were administered suvecaltamide orally 3-2mg capsules twice daily (12 mg/d) on Days 9 to 14. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | CX-8998 Days 15 - 20 (16 mg/d) | Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | CX-8998 Days 21 - 27 (20 mg/d) | Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27. | 0 | 6 | 0 | 6 | 2 | 6 |
| Visual impairment | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Sluggishness | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Baseline (1.029) |
|
| End of Treatment (1.023) |
|
| End of Treatment (1.024) |
|
| End of Treatment (1.026) |
|
| Title | Measurements |
|---|---|
|
| End of Treatment (Turbid) |
|
| Title | Measurements |
|---|---|
|
| Baseline (7) |
|
| End of Treatment (5) |
|
| End of Treatment (5.5) |
|
| Seizure |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|