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NCT Number: NCT03022201

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

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

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Key information

Conditions

Parkinson's Disease,Idiopathic Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cheol Min Shin

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

DA-9701

Drug

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

Domperidone

Drug

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

Placebo domperidone

Drug

Placebo DA-9701

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 16, 2017
Registry last updated
Mar 21, 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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