Clinical TrialID 7482
A Pharmacodynamics and Safety Study of DSP-9632P in Patients With Levodopa-Induced Dyskinesia in Parkinson's Disease
NCT05435729
Levodopa-induced Dyskinesia|Parkinson's Disease
Relationship Network
Interactive first-hop connections across herbs, ingredients, formulas, targets, diseases, symptoms, syndromes, evidence, and monographs.
Click a node to open it in a new tab
Trial: 1Ingredient: 1Links: 1
Arranging relationship network...
Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7482
- Evidence Id
- 7482
- Core Evidence Id
- 7482
- Source Clinical Trial Id
- 7477
- Herb2 Clinical Trial Id
- HBCT007477
- Nct Id
- NCT05435729
- Title
- A Pharmacodynamics and Safety Study of DSP-9632P in Patients With Levodopa-Induced Dyskinesia in Parkinson's Disease
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Levodopa-induced Dyskinesia|Parkinson's Disease
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: DSP-9632P 27.5 mg|DRUG: DSP-9632P 82.5 mg|DRUG: Placebo|DRUG: DSP-9632P 55.0 mg|DRUG: Levodopa formulation
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 7
- Outcome Measure
- Binding potential of 11C-raclopride and Dopamine D2 receptor occupancy by Positron Emission Tomography (PET) in Part A, Evaluate the amount of striatal dopamine release derived from levodopa following single transdermal administration of DSP-9632P using 11C-raclopride PET in patients with levodopa-induced dyskinesia in Parkinson's disease, 1 day|Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation in Part B, Evaluate the Incidence of AEs, SAEs, and AEs leading to treatment discontinuation of DSP-9632P following multiple once-daily transdermal administration for 7 days in patients with levodopa-induced dyskinesia in Parkinson's disease transdermal administration for 7 days in patients with levodopa-induced dyskinesia in Parkinson's disease, 7 days
- Sponsor Collaborator
- Sumitomo Pharma Co., Ltd.
- Funded By
- INDUSTRY
- Location
- Nippon Medical School Hospital, Bunkyo, Tokyo, Japan
- Other Id
- DD701105|jRCT2031220051
- Start Date
- 2022-05-31
- Primary Completion Date
- 2022-11-30
- Completion Date
- 2022-12-02
- First Posted
- 2022-06-28
- Results First Posted
- Last Update Posted
- 2023-08-09
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05435729
- Title Cn
- Title En
- A Pharmacodynamics and Safety Study of DSP-9632P in Patients With Levodopa-Induced Dyskinesia in Parkinson's Disease
- Bilingual Status
- semi_complete