Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06055985
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-09-20
Brief Title:
A Study to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinsons Disease
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
A Multicenter Phase 2 Double-blind Placebo-controlled Randomized Parallel-group Study to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ATLANTIS
Brief Summary:
The primary purpose of this study is to demonstrate the superiority of UCB0022 as an adjunctive treatment to stable dose of standard-of-care SoC including at least levodopa therapy over placebo with regard to motor fluctuations time spent in the OFF state OFF time in study participants with advanced Parkinsons Disease PD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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