Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal Symptoms

Study Overview
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Brief Summary
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The purpose of this study is to determine whether DA-9701(Motilitone) is effective and safe for the treatment on health-related quality of life in Parkinson's disease (PD) patients with gastrointestinal symptoms.

Detailed Description
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Gastrointestinal (GI) symptoms are frequently complained by PD patients. To improve their symptoms, prokinetics are often used in clinics. However, some prokinetics are dopamine receptor antagonist which can aggravate motor symptoms of PD patients or develop tardive dyskinesia when it affects dopamine receptors of the brain. DA-9701 (Motilitone) is recently developed herbal medication which has both 5-HT4 agonism and D2 antagonism. Furthermore, it does not cross the blood brain barrier that can be safely used in PD patients. Hypothetically it has a potential to be a good choice for the treatment of GI symptoms of PD patients. However, there has been no study that evaluates its efficacy and safety by randomized clinical trials in PD patients. This study will evaluate the efficacy and safety of DA-9701 in the double-blind placebo-controlled phase 1 (4 weeks), and the long-term safety of DA-9701 in the open-label phase 2 (8 weeks after phase 1).

Official Title
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Effect of Short-term Motilitone Therapy on Health-related Quality of Life in Parkinson's Disease Patients With Gastrointestinal Symptoms: a Multicenter, Double-blind Randomized, Placebo-controlled Trial

Conditions
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Parkinson Disease, Dyspepsia

Intervention / Treatment
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* Drug: DA-9701
* Drug: DA-9701 placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects were enrolled voluntarily and understood the contents of this clinical trial. Male or female Parkinson disease (PD) patients between 50 and 80 years Subjects who had not received prokinetics (itopride, mosapride, Corydalis tuber, levosulpiride, domperidone, etc.) at least 2 months prior to baseline visit Subjects complained at least one symptom of the following that suggests abnormal bowel functions: anorexia, nausea, abdominal distension, dyspepsia, early satiety, dysphagia, foreign body sensation associated with a meal, symptoms of gastroesophageal reflux, constipation, and defecation problem. Exclusion Criteria: History of a gastrointestinal operation Subjects with active gastrointestinal diseases under treatment of gastroenterology within 1 month Existence of clinically significant cognitive decline or K-Minimental Status Exam score 20 or less Subjects had depression or other psychiatric disorders treated with medications such as antidepressants or antipsychotics; mood tranquilizers, benzodiazepines, and sleep pills were permitted with fixed dose during a period of the clinical trial Subjects with severe active comorbidities which could interfere the quality of life of the patient Subjects with medical conditions which make difficult to be enrolled to the trial judged by clinicians Subjects with hypersensitivity or adverse event related to DA-9701 (Motilitone) Prior participation to other clinical trials within 3 months

Ages Eligible for Study
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Minimum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motilitone arm<br>DA-9701 (Motilitone) 30mg 1T three times per day for 4+8 weeks | Drug: DA-9701<br>* DA-9701 30mg Tablet<br>* Other names: Motilitone;|
| Placebo Comparator: Placebo arm<br>DA-9701 placebo 30mg 1T three times per day for 4 weeks, DA-9701 (Motilitone) 30mg 1T three times per day for 8 weeks | Drug: DA-9701<br>* DA-9701 30mg Tablet<br>* Other names: Motilitone;Drug: DA-9701 placebo<br>* Placebo pill manufactured to mask DA-9701 30mg Tablet<br>* Other names: Motilitone placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Nepean dyspepsia index-Korean version scores | The Nepean dyspepsia index is a tool to measure gastrointestinal symptoms | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bowel movements per day assessed by a bowel habit questionnaire. | Mean bowel movements per day of recent 1 week will be asked using the bowel habit questionnaire. | 4 weeks, 12 weeks | 
| Change in frequency of early satiety per day assessed by a bowel habit questionnaire. | Mean frequency of early satiety per day of recent 1 week will be asked using the bowel habit questionnaire. The frequency will be categorized as following: 0, no event; 1, once a day; 2, twice a day; 3, every meal. | 4 weeks, 12 weeks | 
| Change in frequency of gastric fullness after a meal per day assessed by a bowel habit questionnaire. | Mean frequency of gastric fullness after a meal per day of recent 1 week will be asked using the bowel habit questionnaire. The frequency will be categorized as following: 0, no event; 1, once a day; 2, twice a day; 3, every meal. | 4 weeks, 12 weeks | 
| Change in severity of epigastric pain assessed by a bowel habit questionnaire. | Existence and severity of epigastric pain of recent 1 week will be asked using the bowel habit questionnaire. The severity will be categorized as following: 0, no event; 1, mild; 2, moderate; 3, severe; 4, very severe. | 4 weeks, 12 weeks | 
| Change in the Bristol stool scale score | This is a descriptive picture plate which patients can choose the type of their stool | 4 weeks, 12 weeks | 
| Change in the Unified Parkinson's disease rating scale (UPDRS) scores | This is a measure of the severity of Parkinson's disease | 4 weeks, 12 weeks | 
| Change in the Parkinson's disease quality of life scale (PDQ-39) scores | This is a measure of everyday quality of life affected by Parkinson's disease | 4 weeks, 12 weeks | 
| Change in the Patient global improvement (PGI) scores | This is a measure of patients perception of change in their gastrointestinal symptoms | 4 weeks, 12 weeks | 
| Change in the Clinician global improvement (CGI) scores | This is a measure of clinican's assessment of global clinical status of the patient | 4 weeks, 12 weeks | 
| Change in the Nepean dyspepsia index-Korean version scores | This is a measure of changes in gastrointestinal symptoms at the end of this trial | 12 weeks |