Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-01 @ 8:01 PM
Study NCT ID:
NCT03070132
Status:
WITHDRAWN
Last Update Posted:
2023-05-06
First Post:
2017-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
802NP301 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia
Sponsor:
Biogen
Organization:
Study Overview
Official Title:
A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Trigeminal Neuralgia
Status:
WITHDRAWN
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SURGE-1
Brief Summary:
The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with trigeminal neuralgia (TN). Secondary objectives of this study are to investigate the safety and tolerability of BIIB074 in participants with TN and to evaluate the population pharmacokinetics (PK) of BIIB074.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-001449-16 | EUDRACT_NUMBER | None | View |