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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Parkinson's Disease,Idiopathic

Intervention / Treatment
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* Drug: DA-9701
* Drug: Domperidone
* Drug: Placebo domperidone
* Drug: Placebo DA-9701


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-9701<br>In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks. | Drug: DA-9701<br>* 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.<br>* Other names: Motilitone;Drug: Placebo domperidone<br> <br> |
| Active Comparator: Domperidone<br>(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. | Drug: Domperidone<br>* 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.<br>* Other names: Motilium-M;Drug: Placebo DA-9701<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motilitone