A randomized trial of relamorelin for constipation in Parkinson's disease (MOVE-PD): Trial results and lessons learned

作者:Pfeiffer Ronald F*; Quigley Eamonn M M; Factor Stewart; Fernandez Hubert; McDermott Michael P; Shannon Kathleen; Casaceli Cindy; de Blieck Elisabeth A; Sharma Saloni; Gottesdiener Keith; Hylan Michelle L; Hebert Donald; Dra**y Edward; Freeman Alan; Goudreau John; Deik Andres; Lew Mark; Burack Michelle; Uc Ergun; Kurlan Roger; Morgan John; Malaty Irene; Shukla Aparna Wagle; Brodsky Matthew; Elmer Lawrence; LeWitt Peter; Lannon Margaret; Kawai Connie
来源:Parkinsonism & Related Disorders, 2017, 37: 101-105.
DOI:10.1016/j.parkreldis.2017.02.003

摘要

Background: Bowel dysfunction, including both slow transit constipation and defecatory dysfunction, is a frequent and often troubling nonmotor manifestation of Parkinson's disease (PD). A variety of agents are employed for the treatment of constipation in PD, but dissatisfaction with available treatment approaches is common. Relamorelin is a synthetic ghrelin agonist that has demonstrated prokinetic properties within the gastrointestinal tract. Methods: We carried out a multi-center, randomized, double-blind, placebo-controlled study of relamorelin in patients with PD experiencing chronic, inadequately controlled constipation. Results: Only 18 of an intended 56 subjects completed the trial, in part because of the unexpected occurrence of multiple partially complete bowel movements in constipated PD patients, which made many subjects ineligible for participation. Conclusions: Although recruitment goals were not met, which precluded demonstration of any potential beneficial effect of relamorelin, unique and important insights with regard to the nature of constipation in PD were recognized, which hopefully will lead to more effective clinical trials in the future. It is clear that what PD patients understand as constipation may be more complex than previously realized and does not appear to be characterized by decreased stool frequency alone.

  • 出版日期2017-4