A Double-Blind, Single Center, Randomized, Placebo-Controlled Study of BMS-984923 in Participants With Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

A Phase 1, randomized, double-blind, placebo-controlled study of BMS-984923 administered orally twice daily (BID) for 28 days in participants with Parkinson's disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• Men or women between the ages of 50 and 80 years, inclusive at the time of screening.

• Clinical diagnosis of Parkinson's disease as defined by the United Kingdom Parkinson's disease (PD) Society Brain Bank Clinical Diagnostic Criteria and Movement Disorder Society Parkinson's disease Criteria (must meet both criteria); must include bradykinesia and responsiveness to levodopa.

• Maintenance on stable Parkinson's disease therapy for at least 28 days prior to Screening/Visit 1 through treatment period to Day 42, with demonstratable medication efficacy as assessed by the Investigator.

• Severity of Parkinson's disease symptoms assessed by Hoehn and Yahr Staging score ≤3.0 (assessed in the ON state).

• Maintenance on permitted stable non-Parkinson's disease therapy for at least 28 days prior to Day 1 through the treatment period to Day 42.

• Female participants of childbearing potential must have a negative urine pregnancy test at Screening and baseline, as well as be non-lactating and must agree to use a highly effective method of contraception during the study and for 30 days following last dose of study drug.

• Male participants must be sterile or sexually inactive or agree not to father a child during the study and for 1 month after the last dose of study medication and must agree to use a barrier method for contraception. Female partners of male subjects must adopt a highly effective method of contraception

• Adequate visual, hearing, cognitive and physical ability and willingness to comply with study drug administration, scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study

• Institutional Review Board/Ethics Committee-approved consent form signed and dated by the participant

Locations
United States
North Carolina
Duke Clinical Research Institute
RECRUITING
Durham
Contact Information
Primary
Alexis Schuettke
Alexis.schuettke@duke.edu
919-668-2842
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2025-07-15
Participants
Target number of participants: 18
Treatments
Experimental: 50 mg Active
50mg BID
Experimental: 100mg Active
100mg BID
Placebo_comparator: Matching Placebo
50 and 100 mg matching placebo
Related Therapeutic Areas
Sponsors
Collaborators: Michael J. Fox Foundation for Parkinson's Research
Leads: Allyx Therapeutics

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.