DA-9701 therapy was found to improve the severity of gastrointestinal symptom–related quality of life and severity in patients with Parkinson disease, with no adverse effects on motor symptoms, according to study findings.
DA-9701 therapy was found to improve the severity of gastrointestinal (GI) symptom–related quality of life and severity in patients with Parkinson disease (PD), with no adverse effects on motor symptoms reported, according to study findings published in Movement Disorders.
The prevalence of GI dysfunction is a common issue in those with PD, affecting approximately two-thirds of those with the condition. As noted in a prior webinar, GI issues could have significant implications for antiparkinsonian medication efficacy as slowness of the gut can cause these drugs to have a delayed release and subsequently contribute to OFF periods.
Recently, DA-9701, a prokinetic approved in Korea and sold as Motilitone, has shown promise in several clinical trials of relieving chronic constipation and enhancing gastric emptying in non-PD populations. Researchers sought to examine whether the therapy could also benefit those with PD, particularly GI symptom–related quality of life.
In the multicenter, double-blind, placebo-controlled phase 4 trial, researchers recruited 144 patients with PD with predefined GI dysfunction. Participants were randomized to receive either DA-9701 or placebo for 4 weeks, with both groups then receiving DA-9701 for an additional 8 weeks along with unchanged antiparkinsonian medications.
The study’s primary outcome measure was GI symptoms and related quality-of-life changes at 4 and 12 weeks assessed via the Korean Nepean Dyspepsia Index, with secondary analyses evaluating impact of DA-9701 therapy on parkinsonian motor symptoms at each time point.
In the primary analysis, those administered DA-9701 exhibited significantly improved GI symptom–related quality-of-life scores compared with the placebo group at 4 weeks, determined via linear mixed effect model (adjusted P = .012). These benefits additionally carried over at 12 weeks after intervention, with overall GI symptom and dyspepsia sum scores showing improvements in the DA-9701-first treated group (GI, adjusted P = .002; dyspepsia, P = .014), as well as the placebo-first treated group (GI, adjusted P = .019; dyspepsia, P = .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,” noted researchers.
In addressing study findings, researchers highlighted that results need to be interpreted with caution, as several limitations existed, and indicated that benefits from DA-9701 warrant further studies to delineate long-term safety among the PD population.
Choi JH, Lee JY, Cho JW, et al. Double-blind, randomized, placebo-controlled trial of DA-9701 in Parkinson disease: PASS-GI study. Mov Disord. Published online August 6, 2020. doi:10.1002/mds.28219