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

Phase 4

Completed

• Conditions: Parkinson's Disease,Idiopathic
• Interventions: Drug: DA-9701; Drug: Domperidone; Drug: Placebo domperidone; Drug: Placebo DA-9701

• Registration Number: NCT03022201
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Study First Submitted: 2016-11-23
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-16
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• subjects diagnosed with spontaneous parkinsonism by the United Kingdom(UK) Parkinson's Disease Society Brain Bank criteria
• subjects who are able to explain symptoms they experience and to complete relevant assessment and exams including questionaires
• subjects who understand the purpose and protocols of the study and agree to participate on the study

Exclusion Criteria

• subjects who experience psychiatrical disorders such as cognitive or behavioral disorders
• subjects who are on prokinetics or who are unable to cease such medication
• subjects who present neurological disorders which influence gastrointestinal mobility
• subjects who present gastrointestinal conditions which influence gastrointestinal mobility
• subjects with a history of gastrectomy or colectomy
• subjects who are unable to receive and complete the course of medication due to other metabolic disorders
• subjects diagnosed with parkinson plus syndrome
• subjects who are unable to undergo MRI scan for safety reasons due to claustrophobia or certain devices such as cardiac pacemakers or aneurysm clips

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-9701	Placebo domperidone	In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks.
Domperidone	Placebo DA-9701	(This study is a randomized, double-blinded, non-inferiority trial. Thus it is designed to have no placebo arm.) In this arm, the study participants will receive domperidone 10mg + placebo DA-9701 tablet tid ac +for 4 weeks.
DA-9701	DA-9701	In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks.
Domperidone	Domperidone	(This study is a randomized, double-blinded, non-inferiority trial. Thus it is designed to have no placebo arm.) In this arm, the study participants will receive domperidone 10mg + placebo DA-9701 tablet tid ac +for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment	0, 4 weeks	MRI is known to be accurate and useful in evaluating gastric motility. Gastric emptying rate (GER) evaluated using MRI will be compared before and after the treatment, and between the groups.

Secondary Outcome Measures

Name	Time	Method
Levodopa plasma concentration 30 minutes after the L-dopa administration	0, 4 weeks	Plasma levodopa concentrations will be determined 30 minutes after L-dopa dose administration before and after treatment.
UPDRS Part III score	0, 4 weeks	To evaluate any deteriorations in Parkinson's disease, the investigators will assess Unified Parkinson's Disease Rating Scale (UPDRS) score before and after treatment in the 2 groups.
Patient's symptoms of dyspepsia and constipation assessed patient diary	-1 to 4 weeks	The study participants will fill up the gastrointestinal symptom diary before and during the treatment period. In addition, the investigators will assess the Patient's Global Assessment (PGA) for dyspeptic symptoms at the end of the treatment period.

Trial Locations

Locations (1)

Cheol Min Shin; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of