Parkinson's Disease
Conditions
Brief summary
To assess the preliminary safety and tolerability of multiple oral doses of BIIB014 in subjects with early PD.
Interventions
DRUGactive drug (BIIB014) at 10, 30, 100, or 300 mg once daily.
DRUGplacebo
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking description
Double
Eligibility
Sex/Gender
ALL
Age
30 Years to 78 Years
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): 1. Must give written informed consent. Must also provide all authorizations required by local law. 2. Aged 30 to 78 years old at the time of informed consent. 3. 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. 4. 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. 5. Be Hoehn & Yahr Stage I-III inclusive when OFF. 6. Have a Total Unified PD Rating Scale (UPDRS) OFF score of ³ 8. 7. Have taken no prescribed medications for PD for a minimum of 2 weeks before the Baseline Visit (Day -1). 8. Are willing to abstain from alcohol for the duration of the study. 9. Have no clinically significant baseline ECG (12-lead) and laboratory abnormalities (as determined by the Investigator), unless exempted by the Biogen Idec Medical Director. 10. Agree to provide blood samples for mRNA and DNA analysis, which will be collected and banked and may be used for exploratory pharmacogenomic studies.
Exclusion criteria
Unless otherwise specified, candidates will be excluded from study entry if any of the following
Outcome results
None listed