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Completed

NCT Number: NCT02775591

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyspepsia Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Synucleinopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hanyang University Medical Center, Seoul, South Korea

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-9701

Drug

DA-9701 30mg Tablet

Other names: Motilitone

DA-9701 placebo

Drug

Placebo pill manufactured to mask DA-9701 30mg Tablet

Other names: Motilitone placebo

Primary outcomes

  1. Change in the Nepean dyspepsia index-Korean version scores

    Time frame: 4 weeks

    The Nepean dyspepsia index is a tool to measure gastrointestinal symptoms

Secondary outcomes

  1. Change in bowel movements per day assessed by a bowel habit questionnaire.

    Time frame: 4 weeks, 12 weeks

    Mean bowel movements per day of recent 1 week will be asked using the bowel habit questionnaire.

  2. Change in frequency of early satiety per day assessed by a bowel habit questionnaire.

    Time frame: 4 weeks, 12 weeks

    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.

  3. Change in frequency of gastric fullness after a meal per day assessed by a bowel habit questionnaire.

    Time frame: 4 weeks, 12 weeks

    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. Change in severity of epigastric pain assessed by a bowel habit questionnaire.

    Time frame: 4 weeks, 12 weeks

    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.

  5. Change in the Bristol stool scale score

    Time frame: 4 weeks, 12 weeks

    This is a descriptive picture plate which patients can choose the type of their stool

  6. Change in the Unified Parkinson's disease rating scale (UPDRS) scores

    Time frame: 4 weeks, 12 weeks

    This is a measure of the severity of Parkinson's disease

  7. Change in the Parkinson's disease quality of life scale (PDQ-39) scores

    Time frame: 4 weeks, 12 weeks

    This is a measure of everyday quality of life affected by Parkinson's disease

  8. Change in the Patient global improvement (PGI) scores

    Time frame: 4 weeks, 12 weeks

    This is a measure of patients perception of change in their gastrointestinal symptoms

  9. Change in the Clinician global improvement (CGI) scores

    Time frame: 4 weeks, 12 weeks

    This is a measure of clinican's assessment of global clinical status of the patient

  10. Change in the Nepean dyspepsia index-Korean version scores

    Time frame: 12 weeks

    This is a measure of changes in gastrointestinal symptoms at the end of this trial

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Hanyang University
  • Korea University Guro Hospital
  • SMG-SNU Boramae Medical Center
  • Samsung Medical Center
  • Seoul Veterans Hospital

Registry information

Official study 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

Acronym: PASS-GI

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 17, 2016
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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