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

Primary Purpose

Parkinson's Disease,Idiopathic

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-9701
Domperidone
Placebo domperidone
Placebo DA-9701
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease,Idiopathic focused on measuring Motilitone

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cheol Min Shin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DA-9701

Domperidone

Arm Description

In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks.

(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.

Outcomes

Primary Outcome Measures

Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment
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.

Secondary Outcome Measures

Patient's symptoms of dyspepsia and constipation assessed patient diary
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.
Levodopa plasma concentration 30 minutes after the L-dopa administration
Plasma levodopa concentrations will be determined 30 minutes after L-dopa dose administration before and after treatment.
UPDRS Part III score
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.

Full Information

First Posted
November 23, 2016
Last Updated
March 19, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03022201
Brief Title
Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease,Idiopathic
Keywords
Motilitone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DA-9701
Arm Type
Experimental
Arm Description
In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks.
Arm Title
Domperidone
Arm Type
Active Comparator
Arm Description
(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.
Intervention Type
Drug
Intervention Name(s)
DA-9701
Other Intervention Name(s)
Motilitone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Domperidone
Other Intervention Name(s)
Motilium-M
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo domperidone
Intervention Type
Drug
Intervention Name(s)
Placebo DA-9701
Primary Outcome Measure Information:
Title
Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment
Description
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.
Time Frame
0, 4 weeks
Secondary Outcome Measure Information:
Title
Patient's symptoms of dyspepsia and constipation assessed patient diary
Description
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.
Time Frame
-1 to 4 weeks
Title
Levodopa plasma concentration 30 minutes after the L-dopa administration
Description
Plasma levodopa concentrations will be determined 30 minutes after L-dopa dose administration before and after treatment.
Time Frame
0, 4 weeks
Title
UPDRS Part III score
Description
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.
Time Frame
0, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheol Min Shin, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cheol Min Shin
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29705555
Citation
Shin CM, Lee YJ, Kim JM, Lee JY, Kim KJ, Choi YJ, Kim N, Lee DH. DA-9701 on gastric motility in patients with Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2018 Sep;54:84-89. doi: 10.1016/j.parkreldis.2018.04.018. Epub 2018 Apr 21.
Results Reference
derived

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

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