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BIIB014 · 5 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 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 |
| Arm One | EXPERIMENTAL | Arm 1 of 6 cross-over arms |
| Arm Two | EXPERIMENTAL | Arm 2 of 6 cross-over arms |
| Arm Three | EXPERIMENTAL | Arm 3 of 6 cross-over arms |
| Arm Four | EXPERIMENTAL | Arm 4 of 6 cross-over arms |
| Arm Five | EXPERIMENTAL | Arm 5 of 6 cross-over arms |
| Arm Six | EXPERIMENTAL | Arm 1 of 6 cross-over arms |
| Rosiglitazone 8mg PO | EXPERIMENTAL | Cohort 1 |
| Midazolam 2mg PO, Warfarin 25mg PO | EXPERIMENTAL | Cohort 2 |
| Name | Type | Description |
|---|---|---|
| BIIB014 | DRUG | oral administration of BIIB014 per dose, schedule,and duration specified in protocol |
| Placebo | DRUG | Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014 |
| BIIB014 50mg | DRUG | Single dose oral capsule 50mg BIIB014 |
| BIIB014 100mg | DRUG | Single dose oral capsule 100mg BIIB014 |
| [11C]SCH442416 | OTHER | 11C\]SCH442416 is a radiolabelled tracer molecule that specifically binds to adenosine A2A sites and will be used to evaluate receptor occupancy. The target activity will be 370 MBq. \[11C\]SCH442416 will be administered IV as a bolus injection over 30 seconds following the start of each PET scan. |
Inclusion Criteria: * Must give written informed consent and any authorizations required by local law. * Must carry a diagnosis of idiopathic Parkinson's Disease(PD), without any other known or suspected cause of parkinsonism, according to the UK Parkinson's Disease Society Brain Bank Clinical Diag...
BIIB014 is an investigational small molecule being studied for Parkinson's disease. Clinical trials have evaluated it in patients with early-stage and moderate to late-stage Parkinson's disease, often in combination with levodopa, as well as in healthy volunteers for safety and drug interaction studies.
BIIB014 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. Biogen has sponsored clinical trials of BIIB014 in Parkinson's disease and healthy volunteers.
BIIB014 is in clinical development. While the overall program is listed as Phase 1, completed trials include Phase 1 studies in healthy volunteers and Phase 2 studies in Parkinson's disease patients. All three trials listed for BIIB014 have been completed, and it remains an investigational drug.
BIIB014 has been studied in three completed clinical trials. NCT00438607 was a Phase 2 dose-finding study in moderate to late-stage Parkinson's disease with levodopa. NCT00442780 was a Phase 2 study in early-stage Parkinson's disease. NCT00531193 was a Phase 1 PET scan study in healthy male volunteers.
BIIB014 is the investigational code name used by Biogen for this small molecule. No alternative names have been disclosed in the clinical trial records, so it is primarily known by the identifier BIIB014 in research and development contexts.