At a glance
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET)
In Brief
A Phase 2 clinical trial evaluating Active Investigational Treatment ENT-01 and Placebo Treatment for Constipation and Parkinson Disease. Completed, enrolled 151 participants across 51 sites.
Detailed Summary
This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled study. Approximately 72 patients will be randomized 3:1 to treatment or placebo, with approximately 54 patients allocated to receive the active investigational product and approximately 18 patients allocated to receive placebo. \- Study Update- Amendment 3 - In this amendment, an additional 80 patients (approximately) will be randomized 1:1 to treatment or placebo (double-blind) with approximately 40 subjects allocated to each group.
Study Details
Timeline
Interventions
ENT-01 will be administered in tablet form, once daily.
Placebo will be administered in tablet form, once daily.