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

NCT ID: NCT03022201

Last Updated: 2019-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-06-30

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.

Conditions

Parkinson's Disease,Idiopathic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DA-9701

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

Group Type: EXPERIMENTAL

DA-9701

Intervention Type: 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.

Placebo domperidone

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Domperidone

Intervention Type: 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.

Placebo DA-9701

Intervention Type: DRUG

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo domperidone

Intervention Type: DRUG

Placebo DA-9701

Intervention Type: DRUG

Other Intervention Names

Motilitone; Motilium-M

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheol Min Shin, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Cheol Min Shin

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 29705555 (View on PubMed)

Other Identifiers

B-1210/173-006

Identifier Type: -

Identifier Source: org_study_id