NCT05297201

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

Phase II, Double Blind, Randomized, Placebo Controlled, Parallel Group, Trial to Explore the Potential Anti-dyskinetic Properties of CPL500036 (PDE10A Inhibitor) in Patients with Parkinson's Disease Suffering from Levodopa Induced Dyskinesia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Celon Pharma SA · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a double-blind, randomized, placebo-controlled, parallel-group, dose ranging study, to explore the efficacy, safety, tolerability and pharmacokinetic (PK) of low and high dose of CPL500036 an phosphodiesterase 10A (PDE10A) inhibitor in Parkinson's disease patients with levodopa induced dyskinesia (LID) when administered for 28 days. The study will be conducted at multiple Clinical Sites. Approximately 108 patients will be randomized at 1:1:1 ratio to receive low or high dose of CPL500036 or placebo in a blinded manner, once daily for 28 days (Day 1 to Day 28). The study will comprise of Screening, Baseline (a 4-day in-house period), a Treatment Period and a Follow-Up Period. The patients will be discharged from clinical units during the Treatment Period. Approximately 30% of the patients (11 patients in each of the 3 treatment groups) will undergo extensive PK blood sampling during the Treatment Period and the remaining 70% of the patients will undergo sparse PK blood sampling. Patients from extensive PK blood sampling will be discharged from the Clinical Site on Day 8 and Day 1 for patients from sparse PK blood sampling group respectively.

Conditions

• Parkinson Disease
• Dyskinesia, Medication-Induced

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-02
• Primary completion: 2025-01-13
• Completion: 2025-01-27
• First posted: 2022-03-28
• Last updated: 2025-03-04

Locations

16 sites across 2 countries: Poland, Ukraine