Parkinson Disease Clinical Trial
Official title:
Phase 2A, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BTRX-246040 in Parkinson's Disease Subjects With Motor Fluctuations
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and efficacy of BTRX-246040 in subjects with PD who have motor fluctuations and predictable early morning off periods.
Study treatment is 1 day and total duration of the study is up to 36 days, including an
approximate 28-day screening period. The study will consist of 4 sequential, ascending dose
cohorts of 8 subjects each with a 6:2 randomization to BTRX-246040 or placebo. The planned
dosing for each cohort will be 40, 80,120 and 160 mg. After enrollment of the first cohort
has been completed, doses for subsequent cohorts may be modified based on review of the
available data (safety, tolerability, efficacy, and PK) by an unblinded Dosing Review
Committee (DRC). A similar review and determination of dosing for the subsequent cohort will
be performed after completion of each cohort and based on all data available from previous
cohorts.
Subjects who meet entry criteria assessed at the screening visit (up to 28 days prior to Day
1) will present to the clinic on the morning of Day 1 (treatment day) in the practically
defined OFF state (having withheld anti-parkinsonian medications after 10:00 PM the evening
prior). Subjects will be dosed with study drug and remain on site for an 8-hour observation
period with UPDRS Part III motor response, dyskinesia rating and ON/OFF status assessed
pre-dose, every 30 minutes for 4 hours post-dose, and then hourly for 4 additional post-dose
hours (i.e., 8 hours total post-dose) prior to being discharged. Blood for pharmacokinetics
will be collected 6 times at scheduled intervals within the 8-hour observation period. A
follow-up safety visit is scheduled 7 days later.
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