NCT03022201

Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease

Therapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the therapeutic efficacy and safety of DA-9701 with domperidone in patients with Parkinson's disease

Detailed description

To prevent nausea and vomiting induced by anti-parkinsonian drugs, prokinetic drugs are frequently prescribed in patients with Parkinson's disease (PD). Additionally, there has been some evidence that prokinetics might improve PD symptom fluctuations. From this background, the investigators will evaluate the therapeutic efficacy and safety of DA-9701 in PD patients. In this study, 40 patients will be enrolled and randomly allocated 1:1 to receive either domperidone or DA-9701. The gastric function of each study participant will be evaluated using the MRI technique before and after 4 weeks of the treatment. The study participants will also be subjected to complete the gastrointestinal symptom diary before and during the treatment period. In addition, plasma levodopa concentrations will be determined 30 minutes after dose administration before and after treatment.

Conditions

• Parkinson's Disease,Idiopathic

Interventions

Type	Name	Description
DRUG	DA-9701	Following 2-week screening period, study participants in this group will be given a standard dose of DA-9701 (30 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.
DRUG	Domperidone	Following 2-week screening period, study participants in this group will be given a standard dose of domperidone (10 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.
DRUG	Placebo domperidone
DRUG	Placebo DA-9701

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2017-01-16
• Last updated: 2019-03-21

Locations

1 site across 1 country: South Korea