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
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease,Idiopathic||Drug: DA-9701 Drug: Domperidone Drug: Placebo domperidone Drug: Placebo DA-9701||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks.
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.
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
- 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.
- 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.
- 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.
- 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.
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
|Korea, Republic of|
|Cheol Min Shin|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707|
|Principal Investigator:||Cheol Min Shin, M.D., Ph.D.||Seoul National University Bundang Hospital|