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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRA CT NO: 2007-000398-47 |
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The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with early-stage Parkinson's Disease.
This study will also explore:
Patients who enter this study will be randomly assigned to receive either BIIB014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Dose Level A of BIIB014 |
|
| 2 | Placebo Comparator | Dose Level B of BIIB014 |
|
| 3 | Placebo Comparator | Dose Level C of BIIB014 |
|
| 4 | Placebo Comparator | Dose Level D of BIIB014 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB014 | Drug | oral administration of BIIB014 per dose, schedule,and duration specified in protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of subjects with adverse events | up to end of study | |
| Assessment of clinical laboratory parameters. | up to end of study | |
| Assessment of vital signs. | up to end of study | |
| Assessment of ECG parameters. | up to end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma. | up to end of study | |
| Explore BIIB014 activity by evaluating standard Parkinson's disease assessments. | up to end of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Biogen Idec, MD | Cambridge, MA USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ashkelon | Israel | ||||
| Research Site |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C547274 | 3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine |
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| Placebo | Drug | Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014 |
|
| Explore the PK/pharmacodynamic relationships for BIIB014. | up to end of study |
| Petah Tikva |
| Israel |
| Research Site | Ramat Gan | Israel |
| Research Site | Tel Aviv | Israel |
| Research Site | Kielce | Poland |
| Research Site | Krakow | Poland |
| Research Site | Poznan | Poland |
| Research Site | Warsaw | Poland |
| Research Sites | Belgrade | Serbia |
| Research Site | Belgrade | Serbia |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |