Completed Phase 2a Study in Parkinson’s Disease
A Multicenter, Single-Dose, Multiple-Dose, Randomized, 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.
The study has been published on ClinicalTrials.gov under the title ‘Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson’s Disease Related Constipation (RASMET)’ and ClinicalTrials.gov Identifier NCT03047629. Also, there is some additional information about the study on the Michael J. Fox Foundation website.
The study has now completed. The study was conducted at multiple US sites and 50 patients were enrolled over a 10-month period. In the first stage, single escalating doses of ENT-01 were administered to 10 patients and titrated to tolerability. In stage 2, daily escalating doses were administered to 40 patients and titrated to a clinically efficacious or maximum dose, followed by a randomized withdrawal period. Participating sites included Tampa Bay, Sarasota, Boca Raton, Port Charlotte, Georgetown, Los Angeles, New York, Philadelphia, Cleveland, Detroit, Michigan, Denver and others. For further information, please go to ClinicalTrials.gov or contact us using the Contact Form on this website.