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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
Research Site
Ashkelon, Israel
Research Site
Petah Tikva, Israel
Research Site
Ramat Gan, Israel
Research Site
Tel Aviv, Israel
Research Site
Kielce, Poland
Research Site
Krakow, Poland
Research Site
Poznan, Poland
Research Site
Warsaw, Poland
Research Sites
Belgrade, Serbia
Research Site
Belgrade, Serbia
Number and proportion of subjects with adverse events
Time frame: up to end of study
Assessment of clinical laboratory parameters.
Time frame: up to end of study
Assessment of vital signs.
Time frame: up to end of study
Assessment of ECG parameters.
Time frame: up to end of study
Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma.
Time frame: up to end of study
Explore BIIB014 activity by evaluating standard Parkinson's disease assessments.
Time frame: up to end of study
Explore the PK/pharmacodynamic relationships for BIIB014.
Time frame: up to end of study
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