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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
147
DA-9701 30mg Tablet
Placebo pill manufactured to mask DA-9701 30mg Tablet
Hanyang University Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Boramae Hospital
Seoul, South Korea
Change in the Nepean dyspepsia index-Korean version scores
The Nepean dyspepsia index is a tool to measure gastrointestinal symptoms
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 4 weeks, 12 weeks
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Veterans Healthcare Service Medical Center
Seoul, South Korea
Change in the Unified Parkinson's disease rating scale (UPDRS) scores
This is a measure of the severity of Parkinson's disease
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks