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Efficacy, Safety, Tolerability, and Biomarker Effects of GT-02287 in Early Parkinson's Disease
Sponsor: Gain Therapeutics, Inc.
Summary
The purpose of this study is to assess the efficacy, the safety, and the effect on biomarkers of 2 dose levels of oral GT-02287 over placebo after 48 weeks of treatment in treated and untreated participants with early PD.
Official title: A Randomized, Placebo-controlled, Double-blind, Phase 2a Study to Evaluate the Clinical Efficacy, Safety, Tolerability, and Biomarker Effects of 2 Dose Levels of GT-02287 in Participants With Early Parkinson's Disease
Key Details
Gender
All
Age Range
30 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
111
Start Date
2026-05-30
Completion Date
2028-06-30
Last Updated
2025-12-12
Healthy Volunteers
No
Conditions
Interventions
Low Dose GT-02287
Sachets containing 400 mg/day or 600 mg/day of active (GT-02287), depending on the participant's body weight. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water.
High Dose GT-02287
Sachets containing 800 mg/day or 1000 mg/day of active (GT-02287), depending on the participant's body weight. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water.
Placebo
Sachets containing 420 to 1200 mg of MAS indistinguishable from the active sachets. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water.