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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003265-19 | EudraCT Number |
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| Name | Class |
|---|---|
| The Parkinson Study Group | NETWORK |
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The purpose of the study is to assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage Parkinson's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB0599 High Dose Arm | Experimental | Participants will be randomized to receive a predefined high dosage of UCB0599 during the Treatment Period. |
|
| Placebo Arm | Placebo Comparator | Participants will be randomized to receive a predefined dosage of Placebo during the Treatment Period. |
|
| UCB0599 Low Dose Arm | Experimental | Participants will be randomized to receive a predefined low dosage of UCB0599 during the Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB0599 | Drug | Drug: UCB0599 Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive UCB0599 in a pre-specified sequence during the Treatment Period. |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Day 0 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | Day 0 |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 2 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | Month 2 |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 4 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| MDS-UPDRS Part III Subscale | MDS-UPDRS part III includes motor items assessing speech, facial expression, rigidity, finger tapping, hand movements, pronation supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement (body bradykinesia), postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, and constancy of rest tremor. It included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pd0053 50140 | Birmingham | Alabama | 35233 | United States | ||
| Pd0053 50506 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37460603 | Derived | Price DL, Khan A, Angers R, Cardenas A, Prato MK, Bani M, Bonhaus DW, Citron M, Biere AL. In vivo effects of the alpha-synuclein misfolding inhibitor minzasolmin supports clinical development in Parkinson's disease. NPJ Parkinsons Dis. 2023 Jul 17;9(1):114. doi: 10.1038/s41531-023-00552-7. |
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Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
The Participant Flow refers to the Randomized Set.
The study started to enroll participants in December 2020 and concluded in September 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period. |
| FG001 | UCB0599 180 mg/Day | Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 21, 2024 | Oct 17, 2025 |
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| Placebo | Drug | Drug: Placebo Pharmaceutical form: Capsules Route of administration: Oral use Participants will receive Placebo in a pre-specified sequence during the Treatment Period. |
|
| Month 4 |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 6 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | Month 6 |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 8 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | Month 8 |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 10 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | Month 10 |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 12 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | Month 12 |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 14 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | Month 14 |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 16 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | Month 16 |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 18 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | Month 18 |
| Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18 |
| MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items | The early-stage Parkinson's disease (ePD) subscore is derived from a 15-item subset of the MDS-UPDRS Part III (Motor Examination). It includes all rigidity assessments (neck, upper limbs [right/left], and lower limbs [right/left]) and bradykinesia-related tasks: finger tapping (right/left), hand movements (right/left), pronation-supination of hands (right/left), toe tapping (right/left), and leg agility (right/left). Each item is scored on a 5-point likert scale (0 = no problem to 4 = severe), resulting in a total ePD subscore range of 0 to 60. Higher scores indicate greater motor impairment, while lower scores reflect better motor function. | Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18 |
| MDS-UPDRS Part II Subscale | MDS-UPDRS part II includes motor items assessing speech, saliva and drooling, chewing and swallowing, eating tasks (cutting food and handling utensils), dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed, a car or a deep chair, walking and balance, and freezing. Each of the items in the UPDRS is measured on a scale. It included 13-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II was 0-52, with higher scores reflecting greater severity. | Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18 |
| MDS-UPDRS Part I Subscale | MDS-UPDRS part I include several non-motor aspects of experiences of daily living including cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome during part 1A and sleep problems, daytime sleepiness, pain and other sensation, urinary problems, constipation problems, lightheadedness on standing, and fatigue during Part 1B. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by participant (Range 0-28). Each of items in UPDRS is measured on a scale of 0 to 4, where 0 is normal and 4 (higher score) represents severe abnormalities/worse outcome. Total Score Range 0 to 52. Total score is sum of Part IA (0-24) and Part IB (0-28) subscale scores. Higher scores indicated greater severity of non-motor symptoms. | Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18 |
| Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II | The participant was considered to have an emerging symptom for the item, if the change from Baseline for the item is greater than 0 for 2 consecutive visits. The magnitude of change from Baseline was not considered to determine the emerging symptom. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II includes motor items assessing speech, saliva and drooling, chewing and swallowing, eating tasks (cutting food and handling utensils), dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed, a car or a deep chair, walking and balance, and freezing. This included 13-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II was 0-52, with higher scores reflecting greater severity. | Baseline to Month 18 |
| Time to Worsening of the Disease as Measured by MDS-UPDRS Part III | Time to worsening of the disease on the MDS-UPDRS III scale as defined by a 5-point increase in MDS-UPDRS III, within the 18-month period. MDS-UPDRS part III includes motor items assessing speech, facial expression, rigidity, finger tapping, hand movements, pronation supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement (body bradykinesia), postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, and constancy of rest tremor. It included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. | Baseline to Month 18 |
| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) is a standardized screening tool used to evaluate mild cognitive impairment across multiple cognitive functions i.e. visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. The total possible score is calculated by summing the scores across all functions ranges from: 0 to 30. A score of 26 or above is considered normal, a lower score indicates cognitive impairment. | Screening, Month 18 |
| Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR) | The change from screening in mean striatum specific binding ratios (SBR) was assessed by DaT-SPECT using 123I-Ioflupane as radiopharmaceutical. The whole striatum was calculated as the average of the SBR data values for the four following "small" regions: left caudate small, left putamen small, right caudate small and right putamen small. The SBR was calculated for each region with the occipital cortex as a reference region, where a lower SBR indicates worse disease. The following formula was used to calculate this: (Average [Small region] - Average [Occipital region])/ (Average [Occipital region]). | Screening, Months 12 and 18 |
| Time to Start of Symptomatic Treatment (ST) | Time to start of symptomatic treatment (ST) within the 18-month period. | Baseline to Month 18 |
| Symptomatic Treatment (ST) Intake | Cumulative number of participants on symptomatic treatment (ST) at 18 months are reported. | Month 18 |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE is defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment. | From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months) |
| Percentage of Participants With Serious TEAEs | Serious adverse event: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. | From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months) |
| Percentage of Participants With TEAEs Leading to Participant Withdrawal | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE is defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment. | From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months) |
| Phoenix |
| Arizona |
| 85004-1150 |
| United States |
| Pd0053 50081 | Phoenix | Arizona | 85013 | United States |
| Pd0053 50391 | Tucson | Arizona | 85710 | United States |
| Pd0053 50539 | Little Rock | Arkansas | 72205 | United States |
| Pd0053 50519 | Fountain Valley | California | 92708 | United States |
| Pd0053 50385 | Fresno | California | 93710 | United States |
| Pd0053 50416 | La Jolla | California | 92037 | United States |
| Pd0053 50118 | Los Angeles | California | 90033-5315 | United States |
| Pd0053 50531 | Englewood | Colorado | 80113 | United States |
| Pd0053 50392 | Danbury | Connecticut | 06810 | United States |
| Pd0053 50538 | Farmington | Connecticut | 06030 | United States |
| Pd0053 50396 | Boca Raton | Florida | 33486 | United States |
| Pd0053 50524 | Bradenton | Florida | 34205 | United States |
| Pd0053 50199 | Miami | Florida | 33136 | United States |
| Pd0053 50394 | Tampa | Florida | 33613 | United States |
| Pd0053 50544 | Augusta | Georgia | 30912-0004 | United States |
| Pd0053 50401 | Chicago | Illinois | 60611 | United States |
| Pd0053 50310 | Chicago | Illinois | 60612-3863 | United States |
| Pd0053 50399 | Winfield | Illinois | 60190 | United States |
| Pd0053 50549 | Iowa City | Iowa | 52242 | United States |
| Pd0053 50074 | Kansas City | Kansas | 66160 | United States |
| Pd0053 50121 | Lexington | Kentucky | 40536-0284 | United States |
| Pd0053 50395 | New Orleans | Louisiana | 70121 | United States |
| Pd0053 50529 | Baltimore | Maryland | 21201-1606 | United States |
| Pd0053 50547 | Baltimore | Maryland | 21287 | United States |
| Pd0053 50243 | Boston | Massachusetts | 02114 | United States |
| Pd0053 50546 | Worcester | Massachusetts | 01655 | United States |
| Pd0053 50386 | Farmington Hills | Michigan | 48334 | United States |
| Pd0053 50536 | Saint Paul | Minnesota | 55130 | United States |
| Pd0053 50397 | Las Vegas | Nevada | 89104 | United States |
| Pd0053 50299 | New Brunswick | New Jersey | 08903 | United States |
| Pd0053 50077 | New York | New York | 10021 | United States |
| Pd0053 50521 | New York | New York | 10029 | United States |
| Pd0053 50119 | New York | New York | 10032 | United States |
| Pd0053 50530 | Stony Brook | New York | 11794 | United States |
| Pd0053 50535 | Williamsville | New York | 14221 | United States |
| Pd0053 50372 | Cleveland | Ohio | 44106 | United States |
| Pd0053 50311 | Cleveland | Ohio | 44195 | United States |
| Pd0053 50255 | Columbus | Ohio | 43210 | United States |
| Pd0053 50527 | Toledo | Ohio | 43606 | United States |
| Pd0053 50398 | Tulsa | Oklahoma | 74136 | United States |
| Pd0053 50510 | Portland | Oregon | 97239 | United States |
| Pd0053 50526 | Philadelphia | Pennsylvania | 19107 | United States |
| Pd0053 50084 | Charleston | South Carolina | 29425 | United States |
| Pd0053 50532 | Knoxville | Tennessee | 37920 | United States |
| Pd0053 50543 | Memphis | Tennessee | 38157 | United States |
| Pd0053 50525 | Houston | Texas | 77030-5301 | United States |
| Pd0053 50113 | Houston | Texas | 77030 | United States |
| Pd0053 50400 | San Antonio | Texas | 78229 | United States |
| Pd0053 50107 | Burlington | Vermont | 05401-1473 | United States |
| Pd0053 50542 | Charlottesville | Virginia | 22908 | United States |
| Pd0053 50410 | Fairfax | Virginia | 22031 | United States |
| Pd0053 50534 | Virginia Beach | Virginia | 23456 | United States |
| Pd0053 50292 | Kirkland | Washington | 98034-3030 | United States |
| Pd0053 50419 | Spokane | Washington | 99202 | United States |
| Pd0053 50402 | Crab Orchard | West Virginia | 25827 | United States |
| Pd0053 50374 | Calgary | Canada |
| Pd0053 50390 | Kelowna | Canada |
| Pd0053 50387 | Ottawa | Canada |
| Pd0053 50389 | Toronto | Canada |
| Pd0053 40197 | Amiens | France |
| Pd0053 40527 | Bordeaux | France |
| Pd0053 40424 | Créteil | France |
| Pd0053 40526 | Lille | France |
| Pd0053 40130 | Marseille | France |
| Pd0053 40635 | Nantes | France |
| Pd0053 40524 | Nîmes | France |
| Pd0053 40525 | Paris | France |
| Pd0053 40131 | Strasbourg | France |
| Pd0053 40528 | Toulouse | France |
| Pd0053 40515 | Berlin | Germany |
| Pd0053 40138 | Bonn | Germany |
| Pd0053 40530 | Dresden | Germany |
| Pd0053 40711 | Erbach im Odenwald | Germany |
| Pd0053 40023 | Erlangen | Germany |
| Pd0053 40710 | Essen | Germany |
| Pd0053 40532 | Haag in Oberbayern | Germany |
| Pd0053 40024 | Hanover | Germany |
| Pd0053 40249 | Kiel | Germany |
| Pd0053 40174 | Mainz | Germany |
| Pd0053 40529 | Marburg | Germany |
| Pd0053 40531 | Regensburg | Germany |
| Pd0053 40555 | Brescia | Italy |
| Pd0053 40533 | Padova | Italy |
| Pd0053 40257 | Roma | Italy |
| Pd0053 40534 | Roma | Italy |
| Pd0053 40697 | Roma | Italy |
| Pd0053 40359 | Nijmegen | Netherlands |
| Pd0053 40694 | Bydgoszcz | Poland |
| Pd0053 40719 | Jelenia Góra | Poland |
| Pd0053 40539 | Katowice | Poland |
| Pd0053 40538 | Krakow | Poland |
| Pd0053 40696 | Krakow | Poland |
| Pd0053 40700 | Lodz | Poland |
| Pd0053 40702 | Lublin | Poland |
| Pd0053 40535 | Oświęcim | Poland |
| Pd0053 40536 | Warsaw | Poland |
| Pd0053 40699 | Warsaw | Poland |
| Pd0053 40705 | Warsaw | Poland |
| Pd0053 40045 | A Coruña | Spain |
| Pd0053 40159 | Barcelona | Spain |
| Pd0053 40267 | Barcelona | Spain |
| Pd0053 40046 | Córdoba | Spain |
| Pd0053 40540 | Madrid | Spain |
| Pd0053 40542 | Móstoles | Spain |
| Pd0053 40352 | Pamplona | Spain |
| Pd0053 40541 | San Sebastián | Spain |
| Pd0053 40049 | Seville | Spain |
| Pd0053 40175 | London | United Kingdom |
| Pd0053 40543 | London | United Kingdom |
| Pd0053 40698 | London | United Kingdom |
| Pd0053 40544 | Motherwell | United Kingdom |
| Pd0053 40306 | Newcastle upon Tyne | United Kingdom |
| Pd0053 40457 | Plymouth | United Kingdom |
| FG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The randomized set (RS) included all study participants who are randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period. |
| BG001 | UCB0599 180 mg/Day | Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period. |
| BG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||
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| Primary | Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Day 0 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | Full analysis set (FAS) included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment. | Posted | Mean | Standard Deviation | score on a scale | Day 0 |
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| Primary | Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 2 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment. | Posted | Mean | Standard Deviation | score on a scale | Month 2 |
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| Primary | Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 4 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment. | Posted | Mean | Standard Deviation | score on a scale | Month 4 |
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| Primary | Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 6 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Primary | Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 8 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment. | Posted | Mean | Standard Deviation | score on a scale | Month 8 |
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| Primary | Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 10 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment. | Posted | Mean | Standard Deviation | score on a scale | Month 10 |
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| Primary | Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 12 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| Primary | Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 14 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment. | Posted | Mean | Standard Deviation | score on a scale | Month 14 |
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| Primary | Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 16 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment. | Posted | Mean | Standard Deviation | score on a scale | Month 16 |
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| Primary | Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 18 | MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment. | Posted | Mean | Standard Deviation | score on a scale | Month 18 |
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| Secondary | MDS-UPDRS Part III Subscale | MDS-UPDRS part III includes motor items assessing speech, facial expression, rigidity, finger tapping, hand movements, pronation supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement (body bradykinesia), postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, and constancy of rest tremor. It included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment and number analyzed (n) signifies participants who were evaluable at specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18 |
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| Secondary | MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items | The early-stage Parkinson's disease (ePD) subscore is derived from a 15-item subset of the MDS-UPDRS Part III (Motor Examination). It includes all rigidity assessments (neck, upper limbs [right/left], and lower limbs [right/left]) and bradykinesia-related tasks: finger tapping (right/left), hand movements (right/left), pronation-supination of hands (right/left), toe tapping (right/left), and leg agility (right/left). Each item is scored on a 5-point likert scale (0 = no problem to 4 = severe), resulting in a total ePD subscore range of 0 to 60. Higher scores indicate greater motor impairment, while lower scores reflect better motor function. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment and 'n' signifies participants who were evaluable at specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18 |
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| Secondary | MDS-UPDRS Part II Subscale | MDS-UPDRS part II includes motor items assessing speech, saliva and drooling, chewing and swallowing, eating tasks (cutting food and handling utensils), dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed, a car or a deep chair, walking and balance, and freezing. Each of the items in the UPDRS is measured on a scale. It included 13-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II was 0-52, with higher scores reflecting greater severity. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment and 'n' signifies participants who were evaluable at specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18 |
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| Secondary | MDS-UPDRS Part I Subscale | MDS-UPDRS part I include several non-motor aspects of experiences of daily living including cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome during part 1A and sleep problems, daytime sleepiness, pain and other sensation, urinary problems, constipation problems, lightheadedness on standing, and fatigue during Part 1B. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by participant (Range 0-28). Each of items in UPDRS is measured on a scale of 0 to 4, where 0 is normal and 4 (higher score) represents severe abnormalities/worse outcome. Total Score Range 0 to 52. Total score is sum of Part IA (0-24) and Part IB (0-28) subscale scores. Higher scores indicated greater severity of non-motor symptoms. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment and 'n' signifies participants who were evaluable at specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18 |
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| Secondary | Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II | The participant was considered to have an emerging symptom for the item, if the change from Baseline for the item is greater than 0 for 2 consecutive visits. The magnitude of change from Baseline was not considered to determine the emerging symptom. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II includes motor items assessing speech, saliva and drooling, chewing and swallowing, eating tasks (cutting food and handling utensils), dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed, a car or a deep chair, walking and balance, and freezing. This included 13-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II was 0-52, with higher scores reflecting greater severity. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. | Posted | Count of Participants | Participants | Baseline to Month 18 |
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| Secondary | Time to Worsening of the Disease as Measured by MDS-UPDRS Part III | Time to worsening of the disease on the MDS-UPDRS III scale as defined by a 5-point increase in MDS-UPDRS III, within the 18-month period. MDS-UPDRS part III includes motor items assessing speech, facial expression, rigidity, finger tapping, hand movements, pronation supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement (body bradykinesia), postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, and constancy of rest tremor. It included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. | Posted | Mean | 95% Confidence Interval | months | Baseline to Month 18 |
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| Secondary | Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) is a standardized screening tool used to evaluate mild cognitive impairment across multiple cognitive functions i.e. visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. The total possible score is calculated by summing the scores across all functions ranges from: 0 to 30. A score of 26 or above is considered normal, a lower score indicates cognitive impairment. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, 'n' signifies participants who were evaluable at each specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | Screening, Month 18 |
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| Secondary | Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR) | The change from screening in mean striatum specific binding ratios (SBR) was assessed by DaT-SPECT using 123I-Ioflupane as radiopharmaceutical. The whole striatum was calculated as the average of the SBR data values for the four following "small" regions: left caudate small, left putamen small, right caudate small and right putamen small. The SBR was calculated for each region with the occipital cortex as a reference region, where a lower SBR indicates worse disease. The following formula was used to calculate this: (Average [Small region] - Average [Occipital region])/ (Average [Occipital region]). | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment and 'n' signifies participants who were evaluable at each specified timepoints. | Posted | Mean | Standard Deviation | specific binding ratio | Screening, Months 12 and 18 |
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| Secondary | Time to Start of Symptomatic Treatment (ST) | Time to start of symptomatic treatment (ST) within the 18-month period. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. | Posted | Mean | 95% Confidence Interval | months | Baseline to Month 18 |
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| Secondary | Symptomatic Treatment (ST) Intake | Cumulative number of participants on symptomatic treatment (ST) at 18 months are reported. | FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment. | Posted | Count of Participants | Participants | Month 18 |
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| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE is defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment. | Safety set included all randomized study participants who receive at least a partial dose of study medication. | Posted | Number | percentage of participants | From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months) |
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| Secondary | Percentage of Participants With Serious TEAEs | Serious adverse event: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. | Safety set included all randomized study participants who receive at least a partial dose of study medication. | Posted | Number | percentage of participants | From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months) |
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| Secondary | Percentage of Participants With TEAEs Leading to Participant Withdrawal | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE is defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment. | Safety set included all randomized study participants who receive at least a partial dose of study medication. | Posted | Number | percentage of participants | From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months) |
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From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period. | 0 | 164 | 9 | 164 | 102 | 164 |
| EG001 | UCB0599 180 mg/Day | Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period. | 1 | 165 | 13 | 165 | 97 | 165 |
| EG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. | 1 | 164 | 14 | 164 | 89 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (27) | Non-systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA (27) | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (27) | Non-systematic Assessment |
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| Mitral valve prolapse | Cardiac disorders | MedDRA (27) | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (27) | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA (27) | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA (27) | Non-systematic Assessment |
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| Intestinal polyp | Gastrointestinal disorders | MedDRA (27) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (27) | Non-systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA (27) | Non-systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (27) | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (27) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (27) | Non-systematic Assessment |
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| Hepatic cytolysis | Hepatobiliary disorders | MedDRA (27) | Non-systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA (27) | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (27) | Non-systematic Assessment |
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| Coronavirus infection | Infections and infestations | MedDRA (27) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (27) | Non-systematic Assessment |
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| Pneumonia aspiration | Infections and infestations | MedDRA (27) | Non-systematic Assessment |
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| Infectious pleural effusion | Infections and infestations | MedDRA (27) | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA (27) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (27) | Non-systematic Assessment |
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| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (27) | Non-systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA (27) | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (27) | Non-systematic Assessment |
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| Jaw fracture | Injury, poisoning and procedural complications | MedDRA (27) | Non-systematic Assessment |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27) | Non-systematic Assessment |
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| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27) | Non-systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27) | Non-systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27) | Non-systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27) | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA (27) | Non-systematic Assessment |
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| Vocal cord paralysis | Nervous system disorders | MedDRA (27) | Non-systematic Assessment |
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| Urinary bladder polyp | Renal and urinary disorders | MedDRA (27) | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (27) | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA (27) | Non-systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA (27) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27) | Non-systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (27) | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (27) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (27) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (27) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (27) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (27) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (27) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (27) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (27) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (27) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (27) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1-844-599-2273 | UCBCares@ucb.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 21, 2024 | Oct 17, 2025 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| 65 years to <85 years |
|
| Male |
|
| White |
|
| Other/Mixed |
|
| Missing |
|
| Not Hispanic or Latino |
|
| Missing |
|
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
| UCB0599 180 mg/Day |
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period. |
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
|
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|
| OG002 | UCB0599 360 mg/Day | Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| UCB0599 360 mg/Day |
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period. |
|
|
|
|