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

NCT03022201 | Completed Phase 4

• 1 other identifier: B-1210/173-006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson's Disease,Idiopathic

Keywords

Motilitone

Outcome Measures

Primary Outcomes (1)

• Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment

  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.

  0, 4 weeks

Secondary Outcomes (3)

• Patient's symptoms of dyspepsia and constipation assessed patient diary

  -1 to 4 weeks

• Levodopa plasma concentration 30 minutes after the L-dopa administration

  0, 4 weeks

• UPDRS Part III score

  0, 4 weeks

Study Arms (2)

DA-9701

EXPERIMENTAL

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

Drug: DA-9701; Drug: Placebo domperidone

Domperidone

ACTIVE COMPARATOR

(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; Drug: Placebo DA-9701

Interventions

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.

Also known as: Motilitone

DA-9701

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.

Also known as: Motilium-M

Domperidone

Placebo domperidone DRUG

DA-9701

Placebo DA-9701 DRUG

Domperidone

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Cheol Min Shin

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

Location

Related Publications (1)

• 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.

  PMID: 29705555 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

DA-9701; Domperidone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Cheol Min Shin, M.D., Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: January 16, 2017
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 21, 2019

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)