A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease
- Conditions
- Parkinson's Disease
- Registration Number
- NCT03976349
- Lead Sponsor
- Biogen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 82
Key Inclusion Criteria:<br><br> - Ability to understand the purpose and risks of the study and provide signed and<br> dated informed consent and authorization to use confidential health information in<br> accordance with national and local participant privacy regulations.<br><br> - Diagnosed with PD within 7 years at the time of initial enrollment (i.e., at time of<br> SAD enrollment for rollover participants), without major motor fluctuations or<br> dyskinesia that may interfere with study treatment and assessments in the opinion of<br> the investigator after consultation with the Sponsor.<br><br> - Modified Hoehn and Yahr Stage = 3.<br><br>Key Exclusion Criteria:<br><br> - Montreal Cognitive Assessment (MoCA) score less than (<) 23, dementia, or other<br> significant cognitive impairment that, in the opinion of the Investigator, would<br> interfere with study evaluation.<br><br> - History of any brain surgery for PD or a history of focused ultrasound treatment at<br> any time; or history of neuromodulation procedures.<br><br> - Transient ischemic attack or stroke or any unexplained loss of consciousness within<br> 1 year before Screening.<br><br> - History of unstable angina, myocardial infarction, chronic heart failure, or<br> clinically significant conduction abnormalities within 1 year before Screening.<br><br> - Poorly controlled diabetes mellitus, as defined by having dosage adjustment of<br> diabetic medication within 3 months before dosing (Day 1) or glycosylated hemoglobin<br> value greater than or equal to (=) 8 percent (%) at Screening.<br><br> - History or positive test result at Screening for human immunodeficiency virus.<br><br> - History or positive test result at Screening for hepatitis C virus antibody.<br><br>NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Secondary Outcome Measures
Name Time Method Serum Concentrations of BIIB094;Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of BIIB094;Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of BIIB094;Maximum Concentration (Cmax) of BIIB094;Time to Reach Maximum Concentration (Tmax) of BIIB094;Terminal Elimination Half-Life (t1/2) of BIIB094