Ignite Creation Date:
2024-05-06 @ 9:54 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03107052
Status:
TERMINATED
Last Update Posted:
2021-11-09
First Post:
2017-03-23
Brief Title:
A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab TEV-48125 for the Prevention of Cluster Headache
Sponsor:
Teva Branded Pharmaceutical Products RD Inc
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Multicenter Double-Blind Double-Dummy Study to Explore the Long-Term Safety and Efficacy of TEV-48125 for the Prevention of Cluster Headache
Status:
TERMINATED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated after the episodic cluster study was terminated due to a pre specified futility analyses
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENFORCE
Brief Summary:
This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in participants with cluster headache CH Participants who complete the pivotal studies TV48125-CNS-30056 NCT02945046 and TV48125-CNS-30057 NCT02964338 and enroll into the current study will visit the investigational center for investigational medicinal product IMP administration safety and efficacy assessments and blood and urine collections for pharmacokinetics immunogenicity anti-drug antibodies ADAs and biomarker analyses Participants will return to the investigational center for a follow-up visit to evaluate ADAs fremanezumab concentrations biomarkers and safety adverse events and concomitant medications approximately 75 months after the last dose of IMP
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-003172-43 | EUDRACT_NUMBER | None | None |