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A Study to Assess the Safety of BMS-984923 Compared to Placebo, in People With Parkinson's | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study to Assess the Safety of BMS-984923 Compared to Placebo, in People With Parkinson's

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

NCT06309147•Allyx Therapeutics

View on ClinicalTrials.gov

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.

Detailed Description

This double-blind placebo-controlled study will evaluate 28 days of twice daily dosing of BMS-984923 at two dose levels in comparison to placebo in participants with early Parkinson's disease. This research study will assess the safety and tolerability of multiple doses of BMS-984923 for the treatment of early Parkinson's disease and investigate Dopamine transporter levels in the brain measured with single photon emission computed tomography as an early marker of therapeutic response to a treatment that targets synapse restoration.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men or women between the ages of 50 and 80 years, inclusive at the time of screening.
•2. 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.
•3. 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.
•4. Severity of Parkinson's disease symptoms assessed by Hoehn and Yahr Staging score ≤3.0 (assessed in the "ON" state).
•5. 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.
•6. 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.
•7. 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
•8. 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
•9. Institutional Review Board/Ethics Committee-approved consent form signed and dated by the participant

Exclusion Criteria

•1. Diagnosis of secondary or atypical parkinsonism
•2. Severe or disabling fluctuations or dyskinesias that would, in the opinion of the Investigator, interfere with completion of the study
•3. Previous surgical procedure for Parkinson's disease (e.g. Duopa, deep brain stimulation)
•4. Clinically significant cognitive impairment with a Montreal Cognitive Assessment score \<18
•5. Has a history or current evidence of long QT syndrome
•6. Has bradycardia or tachycardia on the electrocardiogram (ECG) at Screening
•7. Clinical or laboratory findings consistent with another primary neurodegenerative disease or cognitive disorder other than Parkinson's disease, including but not limited to, frontotemporal lobar disease, Huntington's disease, progressive supranuclear palsy, multisystem atrophy, Jacob-Creutzfeld Disease, Down's syndrome, amyotrophic lateral sclerosis, seizure disorder, or other infectious, metabolic or systemic disease affecting the central nervous system including but not limited to, syphilis, present hypothyroidism, present vitamin B12 deficiency, or other laboratory abnormalities
•8. Suicidality, defined as active suicidal thoughts or ideation or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide
•9. Currently active major depression as determined by Beck Depression Inventory (BDI)-II score of \>19
•10. Has a history or current diagnosis of a psychiatric disorder such as schizophrenia, bipolar disorder or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders.
+24 more criteria

Locations (1)

Duke Clinical Research Institute

Durham, North Carolina, United States

Key Dates

Start Date

March 15, 2024

Primary Completion Date

February 15, 2025

Completion Date

July 15, 2025

Last Updated

March 18, 2024

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease

Interventions

BMS-9894923

DRUG

Contacts

Alexis Schuettke

CONTACT

919-668-2842 Alexis.schuettke@duke.edu

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Autonomic FailurePure Autonomic Failure+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Assess the Safety of BMS-984923 Compared to Placebo, in People With Parkinson's

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients