A Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects With Early Parkinson's Disease

StatusNot Yet Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years 5 months later Jul 2025 → Jan 2028
See other at-risk trials from Mthera Pharma Co., Ltd.

Record History

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  1. Primary completion pushed from Jul 2025 to Jan 2028 Show 5 more changesShow less
    • Start date: Mar 14, 2025 to Sep 2027
    • Study completion pushed from Sep 2025 to Mar 2028
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description expanded, about 3 words
  2. Primary completion date: Dec 2024 to Jul 2025
    • Start date: Jul 2024 to Mar 14, 2025
    • Study completion date: Jul 2025 to Sep 2025
    v3
  3. Start date: Jan 2024 to Jul 2024v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
A Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects with Early Parkinson's Disease. Primary objective of the study is to evaluate the safety and tolerability of MT101-5 400 mg and 600 mg oral tablet total daily dose compared to Placebo in subjects with Parkinson's Disease.
Trial Details
NCT Number NCT06175767
Lead Sponsor Mthera Pharma Co., Ltd.
Conditions
(from sponsor)		 Parkinson's Disease
Related terms Parkinson Disease
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov