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100mg Active for Parkinson's Disease

Phase 1

Recruiting

Led By Laurie Sanders, Ph.D

Research Sponsored by Allyx Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 days after last dose

Awards & highlights

Study Summary

This trial is testing a new medication called BMS-984923 in people with Parkinson's disease. It is a small study where some participants will receive the new medication and others will receive a placebo.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Specific side effects are not listed but may include typical drug reactions such as nausea, headaches, dizziness or allergic responses. Since it's a Phase 1 trial, part of the purpose is to identify potential side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 days after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 days after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 days after last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment-emergent adverse events (TEAEs)

Secondary outcome measures

Area under the curve for the first 24 hours of dosing (AUC24h) and at steady state as determined by pharmacokinetic modeling

Other outcome measures

Assess changes in motor function

Change from baseline dopamine transporter

To evaluate changes in α-synuclein

Trial Design

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Michael J. Fox Foundation for Parkinson's ResearchOTHER

112 Previous Clinical Trials

535,103 Total Patients Enrolled

Allyx TherapeuticsLead Sponsor

2 Previous Clinical Trials

62 Total Patients Enrolled

Laurie Sanders, Ph.DPrincipal InvestigatorDuke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include enrollment of individuals aged 60 and above?

"Enrollment in this research study is open to individuals aged above 50 years and below 80 years."

Answered by AI

Which group of individuals would be considered the most suitable candidates for participation in this clinical research study?

"Individuals aged between 50 and 80 years old who have been diagnosed with Parkinson's disease are eligible to participate in this study, which aims to recruit approximately 18 participants."

Answered by AI

Has the Food and Drug Administration endorsed the use of 50 milligrams as an effective dosage?

"Based on our team's evaluation at Power, the safety rating for 50 mg Active is ranked as a 1. This reflects the preliminary nature of this Phase 1 trial with minimal evidence supporting both safety and efficacy."

Answered by AI

Are patients currently eligible to participate in this ongoing clinical trial?

"According to clinicaltrials.gov, recruitment for this particular trial is currently closed. The study was first listed on 3/15/2024 and last updated on 3/6/2024. While enrollment is not ongoing for this specific trial, it's worth noting that there are a total of 526 other trials actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Assess the Safety of BMS-984923 Compared to Placebo, in People With Parkinson's". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06309147.

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