NCT05435729

A Pharmacodynamics and Safety Study of DSP-9632P in Patients With Levodopa-Induced Dyskinesia in Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Sumitomo Pharma Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label of single transdermal dose of DSP-9632P to evaluate the dopamine release derived from levodopa in brain, and a randomized, double-blind, placebo-controlled, 2-way crossover of multiple transdermal doses of DSP-9632P to evaluate the safety and tolerability in patients with levodopa-induced dyskinesia in Parkinson's disease.

Detailed description

This study consists of Part A and Part B. Part A is an open-label part to evaluate the amount of striatal dopamine release derived from levodopa following single transdermal administration of DSP-9632P using 11Craclopride PET in patients with levodopa-induced dyskinesia in Parkinson's disease. Part A consists of screening, Period 1, Period 2, Period 3, Period 4, and follow-up period. Each period consists of 2 days, Day 1 and Day 2. There will be a 7-day or longer washout of DSP-9632P between Periods 3 and 4. Subjects will be hospitalized in each period. Part B is a randomized, double-blind, placebo-controlled, crossover part to evaluate the safety and tolerability of DSP-9632P following multiple transdermal administration in patients with levodopa-induced dyskinesia in Parkinson's disease. Part B consists of screening, placebo lead-in period, baseline period, Period 1, Period 2, and follow-up period. Period 1 and Period 2 consist of 9 days. Subjects will be hospitalized for 10 days 9 nights from baseline period to Period 1 and for 9 days 8 nights in Period 2. There will be a 7-day or longer washout of DSP-9632P between Periods 1 and 2. Subjects will concomitantly use any of the levodopa formulation from the time of informed consent to the end of study.

Conditions

• Levodopa-induced Dyskinesia
• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	DSP-9632P 27.5 mg	Single dose of DSP-9632P 27.5 mg
DRUG	DSP-9632P 82.5 mg	Single dose of DSP-9632P 82.5 mg
DRUG	Placebo	Placebo for DSP-9632P
DRUG	DSP-9632P 55.0 mg	Multiple dose of DSP-9632P 55.0 mg
DRUG	Levodopa formulation	Single dose of Levodopa formulation

Timeline

• Start date: 2022-05-31
• Primary completion: 2022-11-30
• Completion: 2022-12-02
• First posted: 2022-06-28
• Last updated: 2023-08-09

Locations

1 site across 1 country: Japan