Double-Blind, Randomized, Placebo-Controlled Trial of DA-9701 in Parkinson's Disease: PASS-GI Study

Ji Hyun Choi, Jee Young Lee, Jin Whan Cho, Seong Beom Koh, Young Soon Yang, Dalla Yoo, Cheol Min Shin, Hee Tae Kim

Research output: Contribution to journalArticle

Abstract

Objectives: This study aimed to assess the efficacy of DA-9701 on gastrointestinal symptom-related quality of life in patients with Parkinson's disease on stable dopaminergic medications. Methods: This multicenter, double-blind, placebo-controlled, phase 4 trial included a total of 144 patients with Parkinson's disease with gastrointestinal dysfunctions based on predefined criteria. Participants were randomized to take either DA-9701 or placebo for 4 weeks, and then both groups were administered DA-9701 for an additional 8 weeks while antiparkinsonian medications were unchanged. The primary outcome measure was gastrointestinal symptoms and related quality-of-life changes assessed on the Korean Nepean dyspepsia index after 4 and 12 weeks of therapy. We also evaluated the impact of DA-9701 therapy on parkinsonian motor symptoms at each time point. Results: The gastrointestinal symptom-related quality-of-life score significantly improved in the DA-9701-treated group compared with the placebo-treated group after 4weeks (adjusted P = 0.012 by linear mixed effect model analysis). The overall gastrointestinal symptom and dyspepsia sum scores improved at 12 weeks after intervention in the DA-9701-first treated group (adjusted P = 0.002 and 0.014, respectively) and also in the placebo-first treated group (adjusted P = 0.019 and 0.039) compared with the baseline. Parkinsonian motor severity was not significantly affected by DA-9701 treatment in both groups at 4 and 12 weeks after intervention. There were no drug-related serious adverse events throughout the trial. Conclusions: DA-9701 therapy improved gastrointestinal symptom-related quality of life, and 12 weeks of daily administration can relieve the overall severity of gastrointestinal symptoms in patients with Parkinson's disease without affecting motor symptoms. (Clinical trial identifier: NCT02775591.)

Original languageEnglish
JournalMovement Disorders
DOIs
Publication statusAccepted/In press - 2020

Keywords

  • DA-9701
  • double-blind randomized controlled trial
  • gastrointestinal dysfunction
  • Parkinson's disease
  • quality of life

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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    Choi, J. H., Lee, J. Y., Cho, J. W., Koh, S. B., Yang, Y. S., Yoo, D., Shin, C. M., & Kim, H. T. (Accepted/In press). Double-Blind, Randomized, Placebo-Controlled Trial of DA-9701 in Parkinson's Disease: PASS-GI Study. Movement Disorders. https://doi.org/10.1002/mds.28219