NCT00442780

Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Doses of BIIB014 Administered Orally in Subjects With Early Parkinson's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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: * How BIIB014 is affected when given to patients with early-stage Parkinson's Disease (this will be done by measuring the levels of BIIB014 in the blood at several different times during the study), and * The activity of BIIB014 when given to early Parkinson's patients (this will be done by performing different Parkinson's Disease assessments and other tests during the study). 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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	BIIB014	oral administration of BIIB014 per dose, schedule,and duration specified in protocol
DRUG	Placebo	Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-03-02
• Last updated: 2009-01-09

Locations

10 sites across 3 countries: Israel, Poland, Serbia