Parkinson's Disease,Idiopathic Clinical Trial
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
This study will evaluate the therapeutic efficacy and safety of DA-9701 with domperidone in patients with Parkinson's disease
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.
;