Phase 2Not yet recruitingAge-related condition
Efficacy, Safety, Tolerability, and Biomarker Effects of GT-02287 in Early Parkinson's Disease
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
- Sponsor
- Gain Therapeutics, Inc. (Industry)
- Enrolment
- 111 planned
- Conditions
- Parkinson Disease
- Interventions
- Low Dose GT-02287; High Dose GT-02287; Placebo
- Ages
- adults, older adults
- Registry
- NCT07280299
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change from Baseline to Week 48 in the sum of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score and Part III score [Efficacy]
History
Primary completion expected
Started
Registered