Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05297201
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2022-02-17
Brief Title:
Efficacy Safety and Pharmacokinetic Study of CPL500036 in Patients With Levodopa Induced Dyskinesia
Sponsor:
Celon Pharma SA
Organization:
Celon Pharma SA
Study Overview
Official Title:
Phase II Double Blind Randomized Placebo Controlled Parallel Group Trial to Explore the Potential Anti-dyskinetic Properties of CPL500036 PDE10A Inhibitor in Patients With Parkinsons Disease Suffering From Levodopa Induced Dyskinesia
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Parkinsons 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 111 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None