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Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients with Levodopa Induced Dyskinesia

NCT05297201 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-03-04

No results posted yet for this study

Summary

The aim of the study is to determine potential anti-dyskinetic properties of CPL500036 (PDE10A inhibitor) in Parkinson disease patients suffering from levodopa Induced dyskinesia. The study is to determine the efficacy and dose response of two CPL500036 doses, compared with placebo.

Conditions

  • Parkinson Disease
  • Dyskinesia, Medication-Induced

Interventions

DRUG

CPL500036 - low dose

CPL500036 will be given orally. Each patient is to take 2 capsules with active substance and 2 capsules of placebo daily.

DRUG

CPL500036 - high dose

CPL500036 will be given orally. Each patient is to take 4 capsules with active substance daily.

DRUG

Placebo

Placebo will be given orally. Each patient is to take 4 capsules of placebo daily.

Sponsors & Collaborators

  • National Center for Research and Development, Poland

    collaborator OTHER

  • Celon Pharma SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2025-01-13
Completion
2025-01-27

Countries

  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT05297201 on ClinicalTrials.gov