Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04658186
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2020-12-01
Brief Title:
A 18-month Study to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinsons Disease
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Randomized 18-Month Phase 2a Study to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2024-09
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:
ORCHESTRA
Brief Summary:
The purpose of the study is to assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage Parkinsons Disease
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003265-19 | EUDRACT_NUMBER | None | None |