NCT00451815
Withdrawn
Phase 2
A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Oral Dose Administration of BIIB014 in Subjects With Early Parkinson's Disease
ConditionsParkinson's Disease
Overview
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Biogen
Overview
Brief Summary
To assess the preliminary safety and tolerability of multiple oral doses of BIIB014 in subjects with early PD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Masking Description
Double
Eligibility Criteria
- Ages
- 30 Years to 78 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the Baseline Visit (Day -1):
- •Must give written informed consent. Must also provide all authorizations required by local law.
- •Aged 30 to 78 years old at the time of informed consent.
- •If female, must be postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded.
- •Carry a diagnosis of probable idiopathic PD, made by a Movement Disorder Specialist, with asymmetric onset and at least 2 of the following cardinal features of PD: bradykinesia, rigidity, or a classic PD resting tremor.
- •Be Hoehn \& Yahr Stage I-III inclusive when OFF.
- •Have a Total Unified PD Rating Scale (UPDRS) OFF score of ³
- •Have taken no prescribed medications for PD for a minimum of 2 weeks before the Baseline Visit (Day -1).
- •Are willing to abstain from alcohol for the duration of the study.
- •Have no clinically significant baseline ECG (12-lead) and laboratory abnormalities (as determined by the Investigator), unless exempted by the Biogen Idec Medical Director.
Exclusion Criteria
- Not provided
Investigators
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