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BIIB014

Phase 2

Parkinson's Disease | Small molecule | Neurology |Biogen Inc.|Trials Updated: Jul 13, 2009

BIIB014 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Feb 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment119

FDA Designations

No designations recorded

BIIB014 clinical trials

BIIB014 · 2 trials · 1 indication

Phase 2 2
NCT00442780Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's DiseaseParkinson's Disease
COMPLETED36 Analytics
NCT00438607Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's DiseaseParkinson's Disease
COMPLETED83 Analytics
PHASE2COMPLETED
Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease
Parkinson's DiseaseUnlock trial analytics
PHASE2COMPLETED
Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease
Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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
Assessment of clinical laboratory parameters
up to end of study
Assessment of vital signs
up to end of study

Secondary Endpoints

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
Explore the PK/pharmacodynamic relationships for BIIB014.
up to end of study
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATORDose Level A of BIIB014
2PLACEBO_COMPARATORDose Level B of BIIB014
3PLACEBO_COMPARATORDose Level C of BIIB014
4PLACEBO_COMPARATORDose Level D of BIIB014

Interventions

NameTypeDescription
BIIB014DRUGoral administration of BIIB014 per dose, schedule,and duration specified in protocol
PlaceboDRUGOral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
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Eligibility Criteria

Age Range30 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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...

Countries:IsraelPolandSerbiaIndiaUnited Kingdom
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Frequently asked questions about BIIB014

What is BIIB014?

BIIB014 is an investigational small molecule developed by Biogen Inc. (ticker BIIB) for Parkinson's disease. It is a neurology asset that has been studied in Phase 2 clinical trials. BIIB014 is also known as BIIB014 50mg. It has not been approved by the FDA and remains in clinical development.

What is BIIB014 used for in Parkinson's Disease?

BIIB014 is being studied for the treatment of Parkinson's disease. Two Phase 2 trials evaluated it in early-stage Parkinson's disease and in combination with levodopa in moderate to late stage Parkinson's disease. Both studies are completed, and the drug remains investigational rather than approved for prescribing.

Who makes BIIB014?

BIIB014 is developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is the sponsor of the clinical program studying BIIB014 in Parkinson's disease. The drug is an investigational small molecule and is not currently an approved commercial product.

What phase is BIIB014 in?

BIIB014 is in Phase 2 development. Two Phase 2 dose-finding safety studies have been completed, one in early-stage Parkinson's disease and one in combination with levodopa in moderate to late stage Parkinson's disease. No active trials are currently listed, and the drug is not FDA approved.

What clinical trials is BIIB014 in?

BIIB014 has been studied in two completed Phase 2 trials: NCT00442780, a dose-finding safety study in early-stage Parkinson's disease with 36 participants, and NCT00438607, a dose-finding safety study in combination with levodopa in moderate to late stage Parkinson's disease with 83 participants. Both were randomized, double-blind, and placebo-controlled.