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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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ClinicalTrials.gov Identifier: NCT03022201
Recruitment Status : Completed
First Posted : January 16, 2017
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease,Idiopathic Drug: DA-9701 Drug: Domperidone Drug: Placebo domperidone Drug: Placebo DA-9701 Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Domperidone

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 Name: 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 Name: Motilium-M

Drug: Placebo DA-9701



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022201


Locations
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Korea, Republic of
Cheol Min Shin
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Cheol Min Shin, M.D., Ph.D. Seoul National University Bundang Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03022201     History of Changes
Other Study ID Numbers: B-1210/173-006
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Seoul National University Hospital:
Motilitone

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action