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

March 19, 2019 updated by: Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Cheol Min Shin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DA-9701
In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks.
Drug: DA-9701
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.
Other Names:
  • Motilitone
Drug: Placebo domperidone
ACTIVE_COMPARATOR: Domperidone
(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
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.
Other Names:
  • Motilium-M
Drug: Placebo DA-9701

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment
Time Frame: 0, 4 weeks
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
Time Frame: -1 to 4 weeks
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
Time Frame: 0, 4 weeks
Plasma levodopa concentrations will be determined 30 minutes after L-dopa dose administration before and after treatment.
0, 4 weeks
UPDRS Part III score
Time Frame: 0, 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Cheol Min Shin, M.D., Ph.D., Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

January 13, 2017

First Posted (ESTIMATE)

January 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1210/173-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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