ENT-01

Evidence outlook · lead readout

NCT03781791 · Constipation, Parkinson Disease

The completed lead evidence is positive, with design limits that temper confidence — see the rationale below for exactly which.

NCT03781791: This was a randomized, quadruple-blinded, placebo-controlled Phase 2 trial in about 151 patients with Parkinson's disease-related constipation. The primary efficacy endpoint was change in weekly complete spontaneous bowel movements, and although the numerical improvement appeared larger with ENT-01 (1.1 to 3.9/week) than placebo (1.0 to 2.3/week), the registry reports no p-value or confidence interval, so the primary comparison cannot be confirmed as statistically significant. Safety outcomes favored placebo, with more treatment-related and dose-limiting adverse events in the ENT-01 arm.