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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Parkinson's Disease,Idiopathic

Treatments: Drug: DA-9701; Drug: Domperidone; Drug: Placebo DA-9701; Drug: Placebo domperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT03022201

B-1210/173-006

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

DA-9701

Experimental group

Description:

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

Treatment:

Drug: DA-9701

Drug: Placebo domperidone

Domperidone

Active Comparator group

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.

Treatment:

Drug: Placebo DA-9701

Drug: Domperidone