DA-9701 on gastric motility in patients with Parkinson's disease: A randomized controlled trial.

Abstract

INTRODUCTION:

To evaluate the effect of DA-9701, a novel prokinetic drug, on gastric motility evaluated by magnetic resonance imaging in patients with Parkinson's disease (PD).

METHODS:

Forty PD patients were randomly allocated to receive either domperidone or DA-9701. Their gastric functions were evaluated using magnetic resonance imaging before and after 4-week treatment period. Information on levodopa daily dose, disease duration, and Unified PD Rating Scale scores was collected. In 18 patients (domperidone: 9, DA-9701: 9), plasma levodopa concentrations were determined. Primary outcome was assessed by a one-sided 95% confidence interval to show non-inferiority of DA-9701 vs. domperidone with a pre-determined non-inferiority margin of -10%.

RESULTS:

Thirty-eight participants (19 men and 19 women; mean age, 67.1 years) completed the study protocol (domperidone: DA-9701 = 19:19). Gastric emptying rate at 120 min (2-hr GER) was comparable between the 2 groups; it was not correlated with levodopa daily dose or disease duration or Unified PD Rating Scale scores (all p > 0.05). DA-9701 was not inferior to domperidone in changes of 2-hr GERs before and after the treatment (absolute difference, 4.0 %; one-sided 95% confidence interval, - 3.7 to infinity). However, a significant increase in 2-hr GER was observed only in DA-9701 group (54.5% and 61.8%, before and after treatment, respectively, p < 0.05). Plasma levodopa concentration showed an insignificant but increasing trend in DA-9701 group. There were neither adverse reactions nor deteriorations of parkinsonian symptoms observed in the study participants.

CONCLUSION:

DA-9701 can be used for the patients with PD to enhance gastric motility without aggravating PD symptoms (ClinicalTrials.gov number: NCT03022201).

• Authors: Cheol Min Shin, Yoon Jin Lee, Jong-Min Kim, Jee Young Lee, Kyung-Joon Kim, Yoon Jin Choi, Nayoung Kim, Dong Ho Lee
• Journal: Parkinsonism & related disorders (Parkinsonism Relat Disord) Vol. 54 Pg. 84-89 (09 2018) ISSN: 1873-5126 [Electronic] England
• PMID: 29705555 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 Elsevier Ltd. All rights reserved.

Chemical References

• Antiemetics
• Antiparkinson Agents
• DA-9701
• Plant Preparations
• Levodopa
• Domperidone

Topics

• Aged
• Antiemetics (administration & dosage, pharmacology)
• Antiparkinson Agents (administration & dosage, blood)
• Domperidone (administration & dosage, pharmacology)
• Double-Blind Method
• Female
• Gastric Emptying (drug effects)
• Humans
• Levodopa (administration & dosage, blood)
• Magnetic Resonance Imaging
• Male
• Middle Aged
• Parkinson Disease (drug therapy)
• Plant Preparations (administration & dosage, pharmacology)
• Stomach (diagnostic imaging, drug effects)
• Treatment Outcome