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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-9701 | Experimental | In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's symptoms of dyspepsia and constipation assessed patient diary | The study participants will fill up the gastrointestinal symptom diary before and during the treatment period. In addition, the investigators will assess the Patient's Global Assessment (PGA) for dyspeptic symptoms at the end of the treatment period. | -1 to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheol Min Shin, M.D., Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cheol Min Shin | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29705555 | Derived | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C533973 | DA-9701 |
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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|
|
| 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. |
|
|
| Placebo domperidone | Drug |
|
| Placebo DA-9701 | Drug |
|
| Levodopa plasma concentration 30 minutes after the L-dopa administration |
Plasma levodopa concentrations will be determined 30 minutes after L-dopa dose administration before and after treatment. |
| 0, 4 weeks |
| UPDRS Part III score | To evaluate any deteriorations in Parkinson's disease, the investigators will assess Unified Parkinson's Disease Rating Scale (UPDRS) score before and after treatment in the 2 groups. | 0, 4 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |