MedTrace Logo

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

NCT05435729 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-08-09

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Sumitomo Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2022-11-30
Completion
2022-12-02

Countries

  • Japan

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05435729 on ClinicalTrials.gov