Ignite Creation Date:
2024-05-06 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03339336
Status:
TERMINATED
Last Update Posted:
2021-05-05
First Post:
2017-11-08
Brief Title:
Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Phase 2 Placebo-Controlled Double-Blind Enriched Enrollment Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 Vixotrigine in Treating Pain Experienced by Subjects With Confirmed Small Fiber Neuropathy That is Idiopathic or Associated With Diabetes Mellitus
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision to close study early not due to safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy SFN that is idiopathic or associated with diabetes mellitus A secondary endpoint that relates to the primary objective is the change from Randomization to Week 12 of the double-blind period in mean average daily pain score
The secondary objectives of this study are to evaluate the effect on worst pain neuropathic pain quality sleep interference due to pain patient global impression use of rescue medication and SFN symptoms in participants treated with BIIB074 to investigate the safety and tolerability of BIIB074 in participants with SFN and to characterize the pharmacokinetics PK of BIIB074 in participants with SFN
The secondary objectives of this study are to evaluate the effect on worst pain neuropathic pain quality sleep interference due to pain patient global impression use of rescue medication and SFN symptoms in participants treated with BIIB074 to investigate the safety and tolerability of BIIB074 in participants with SFN and to characterize the pharmacokinetics PK of BIIB074 in participants with SFN
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-000991-27 | EUDRACT_NUMBER | None | None |