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

NCT00442780 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2009-01-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Biogen Idec, MD · Cambridge, MA USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Israel
  • Poland
  • Serbia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00442780 on ClinicalTrials.gov