At a glance
ClinicalIndex Comparison Record- ✓Parkinson's disease diagnosis confirmed by a neurologist specializing in movement disorders
- ✓Constipation for over 6 months, unresponsive to Milk of Magnesia, and requiring at least weekly treatment using an oral laxative, stool softener, bulking agent, and/or a suppository, and dissatisfaction with current treatment
- ✓At least 2 of the Rome IV functional constipation criteria are met
- ✓Body Mass Index is 18-40 kg/m2
- ✕Diagnosis of secondary constipation beyond that of PD
- ✕Structural or metabolic diseases that affect the GI system
- ✕Functional GI disorder
- ✕Unable or unwilling to withdraw from taking the following medications 2 weeks prior to the dose-escalation period and throughout the study: Laxatives, opiates, sedatives, hypnotics, anti-histamines, protein pump inhibitors or any medications which may cause constipation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Single-Dose, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Related Constipation
In Brief
A Phase 2 clinical trial evaluating ENT-01 and Placebo for Parkinson's Disease and Constipation. Completed, enrolled 50 participants across 15 sites.
Detailed Summary
This is a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of an orally-administered medication to relieve symptoms of constipation associated with Parkinson's Disease. Ten patients will be enrolled in Phase 1, and will be studied over an 8-12 week period. Forty patients will be enrolled in Phase 2, and will be studied over an 8-10 week period. All subjects will receive the study drug during one of the observational periods of the study.
Study Details
Timeline
Interventions
Daily dosing with ENT-01. ENT-01 is an orally administered proprietary substance formulated as a small 25mg coated tablet. Dosing will range from 25-200mg, and the dose will be taken upon awakening on an empty stomach with 8oz water simultaneous to dopamine.
Daily dosing with a placebo