Clinical trial NCT02775591: Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal Symptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Dyspepsia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Korea University Guro Hospital
name: Hanyang University
name: Seoul Veterans Hospital
name: SMG-SNU Boramae Medical Center
First posted: 2016-05-17
Enrollment: 147
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Nepean dyspepsia index-Korean version scores
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in bowel movements per day assessed by a bowel habit questionnaire.
timeFrame: 4 weeks, 12 weeks
measure: Change in frequency of early satiety per day assessed by a bowel habit questionnaire.
timeFrame: 4 weeks, 12 weeks
measure: Change in frequency of gastric fullness after a meal per day assessed by a bowel habit questionnaire.
timeFrame: 4 weeks, 12 weeks
measure: Change in severity of epigastric pain assessed by a bowel habit questionnaire.
timeFrame: 4 weeks, 12 weeks
measure: Change in the Bristol stool scale score
timeFrame: 4 weeks, 12 weeks
measure: Change in the Unified Parkinson's disease rating scale (UPDRS) scores
timeFrame: 4 weeks, 12 weeks
measure: Change in the Parkinson's disease quality of life scale (PDQ-39) scores
timeFrame: 4 weeks, 12 weeks
measure: Change in the Patient global improvement (PGI) scores
timeFrame: 4 weeks, 12 weeks
measure: Change in the Clinician global improvement (CGI) scores
timeFrame: 4 weeks, 12 weeks
measure: Change in the Nepean dyspepsia index-Korean version scores
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
city: Seoul
country: Korea, Republic of
facility: Veterans Healthcare Service Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jee-Young Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi JH, Lee JY, Cho JW, Koh SB, Yang YS, Yoo D, Shin CM, Kim HT. Double-Blind, Randomized, Placebo-Controlled Trial of DA-9701 in Parkinson's Disease: PASS-GI Study. Mov Disord. 2020 Nov;35(11):1966-1976. doi: 10.1002/mds.28219. Epub 2020 Aug 6.