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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRA CT NO: 2006-003490-27 | |||
| ISCRTN 12870393 |
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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 moderate to late-stage Parkinson's Disease who are also taking the Parkinson's medication, levodopa (L-DOPA).
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.
The study will be divided into 2 parts:
Note: As Part A of the study is now concluded, some of the study design information presented below (e.g., number of study arms) pertains only to Part B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | BIIB014 at MTD from Part A |
|
| 2 | Other | BIIB014 at dose immediately below MTD from Part A |
|
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB014 | Drug | oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks |
|
| 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 24h following last dose (Part A only) | |
| Explore activity of BIIB014 by evaluating standard Parkinson's disease assessments | up to 8h following last dose (Part A); up to 24h following last dose (Part B only) |
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Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Biogen Idec | Cambridge, MA USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Sites | Bangalore | India | ||||
| Research Site |
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| Placebo | Drug | Matched placebo for MTD or MTD-1 |
|
| Chennai |
| India |
| Research Site | Hyderabaad | India |
| Research Site | Ludhiana | India |
| Research Site | Mumbai | India |
| Research Site | New Delhi | India |
| Research Site | Secunderabad | India |
| Research Site | Ashkelon | Israel |
| Research Site | Jerusalem | Israel |
| Research Site | Ramat Gan | Israel |
| Research Site | Tel Aviv | Israel |
| Research Site | Cambridge | United Kingdom |
| Research Site | Manchester | United Kingdom |
| Research Site | Norwich | United Kingdom |
| Research Site | Salford | United Kingdom |
| 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 |
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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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