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

Parkinson's Disease,Idiopathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022201
• Other study ID #: B-1210/173-006
• Status: Completed
• Phase: Phase 4
• Start date: May 2013
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease,Idiopathic

Intervention

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.
• 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.
• Placebo domperidone

• Placebo DA-9701

Locations

Country	Name	City	State
Korea, Republic of	Cheol Min Shin	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment	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.	0, 4 weeks
Secondary	Patient's symptoms of dyspepsia and constipation assessed patient diary	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.	-1 to 4 weeks
Secondary	Levodopa plasma concentration 30 minutes after the L-dopa administration	Plasma levodopa concentrations will be determined 30 minutes after L-dopa dose administration before and after treatment.	0, 4 weeks
Secondary	UPDRS Part III score	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.	0, 4 weeks