Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-03 @ 6:34 AM
Study NCT ID:
NCT04201093
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2019-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fixed-Dose Trial in Early Parkinson's Disease (PD)
Sponsor:
AbbVie
Organization:
Study Overview
Official Title:
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)
Status:
COMPLETED
Status Verified Date:
2025-07
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:
TEMPO-1
Brief Summary:
The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-002949-38 | EUDRACT_NUMBER | None | View |