18 Participants Needed

BMS-984923 for Parkinson's Disease

TS
PS
AS
Overseen ByAlexis Schuettke
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Allyx Therapeutics
Must be taking: Parkinson's therapy

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stay on your current Parkinson's disease medications and any other stable non-Parkinson's medications for at least 28 days before starting and throughout the study. However, you cannot take medications that might interact with the study drug during the trial.

What data supports the effectiveness of the drug BMS-9894923, ALX-001 for Parkinson's Disease?

The research highlights the potential of targeting metabotropic glutamate receptors, like mGluR4, for treating Parkinson's disease symptoms. Similar treatments, such as TAS-4, have shown promise in animal models by improving movement issues without worsening side effects, suggesting that BMS-9894923, ALX-001 might also be effective.12345

How is the drug BMS-984923 different from other Parkinson's disease treatments?

BMS-984923 (also known as ALX-001) is unique because it may target specific receptors or pathways not addressed by current Parkinson's treatments, potentially offering a new approach to managing symptoms or side effects like dyskinesia (involuntary movements) associated with long-term use of existing medications like L-DOPA.46789

What is the purpose of this trial?

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.

Research Team

LS

Laurie Sanders, Ph.D

Principal Investigator

Duke University

Eligibility Criteria

Adults aged 50-80 with Parkinson's disease, able to follow the study plan and on stable PD therapy. They must not have severe symptoms, cognitive impairment, or a history of certain medical conditions. Participants need to use effective contraception if they can have children.

Inclusion Criteria

Institutional Review Board/Ethics Committee-approved consent form signed and dated by the participant
My Parkinson's symptoms are mild to moderate.
I have been diagnosed with Parkinson's disease and respond to levodopa.
See 6 more

Exclusion Criteria

Suspected or known allergy to any components of the study medication
Thrombocytopenia defined as platelet count <100,000/microliter
Neutropenia defined as absolute neutrophil count of <1,500/microliter
See 31 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-984923 or placebo orally twice daily for 28 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • BMS-9894923
Trial Overview The trial is testing BMS-9894923, an oral medication taken twice daily for 28 days against a placebo in people with Parkinson's Disease to see its effects and safety.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 50 mg ActiveExperimental Treatment1 Intervention
50mg BID
Group II: 100mg ActiveExperimental Treatment1 Intervention
100mg BID
Group III: Matching PlaceboPlacebo Group1 Intervention
50 and 100 mg matching placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Allyx Therapeutics

Lead Sponsor

Trials
4
Recruited
120+

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Trials
117
Recruited
537,000+

Findings from Research

Current dopamine replacement therapies can alleviate motor symptoms of Parkinson's disease, but there is a significant need for improved treatments that also address non-motor symptoms and provide neuroprotection.
Research is focusing on identifying promising biological targets and therapeutic agents, with an emphasis on understanding genetic factors and enhancing the translation of findings from animal models to human clinical trials.
Priorities in Parkinson's disease research.Meissner, WG., Frasier, M., Gasser, T., et al.[2022]
Motor fluctuations and dyskinesias are common and debilitating complications in Parkinson's disease patients within the first few years of treatment, significantly impacting their quality of life.
New therapeutic options, such as subcutaneous apomorphine and deep-brain stimulation, are available for patients who continue to experience motor complications despite optimal medical management, potentially improving both motor and nonmotor symptoms of the disease.
Management of motor complications in Parkinson disease: current and emerging therapies.Espay, AJ.[2013]
The Phase I clinical trial of PF-06669571, a novel dopamine D1 receptor partial agonist, demonstrated that the drug was safe and well tolerated in 20 subjects with Parkinson's disease, with no serious safety concerns reported.
Although the primary endpoint for significant improvement in motor symptoms did not meet pre-specified criteria, a sensitivity analysis suggested potential efficacy, particularly when excluding an outlier with a very high L-DOPA dose.
A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease.Gurrell, R., Duvvuri, S., Sun, P., et al.[2018]

References

Priorities in Parkinson's disease research. [2022]
Management of motor complications in Parkinson disease: current and emerging therapies. [2013]
A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease. [2018]
Therapeutic potential of metabotropic glutamate receptor 4-positive allosteric modulator TAS-4 in rodent models of movement disorders. [2019]
The mGluR2/3 orthosteric agonist LY-404,039 reduces dyskinesia, psychosis-like behaviours and parkinsonism in the MPTP-lesioned marmoset. [2023]
L-745,870 reduces the expression of abnormal involuntary movements in the 6-OHDA-lesioned rat. [2022]
L-745,870 reduces L-DOPA-induced dyskinesia in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine-lesioned macaque model of Parkinson's disease. [2013]
New medical and surgical treatments for Parkinson's disease. [2019]
Levodopa-induced dyskinesias improved by a glutamate antagonist in Parkinsonian monkeys. [2017]
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