Clinical trial NCT03022201: Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease,Idiopathic
Keywords: Motilitone
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment
timeFrame: 0, 4 weeks
Secondary outcomes:
measure: Patient's symptoms of dyspepsia and constipation assessed patient diary
timeFrame: -1 to 4 weeks
measure: Levodopa plasma concentration 30 minutes after the L-dopa administration
timeFrame: 0, 4 weeks
measure: UPDRS Part III score
timeFrame: 0, 4 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Cheol Min Shin
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Cheol Min Shin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.