BTRX-246040 Study in Subjects With Parkinson's Disease With Motor Fluctuations

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Motor Disorder
• Motor Disorders
• Parkinson Disease

• NCT number: NCT03608371
• Study type: Interventional
• Source: BlackThorn Therapeutics, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: August 31, 2018
• Completion date: April 23, 2019