Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-25 @ 4:22 PM
Study NCT ID:
NCT04458857
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2020-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age
Status:
COMPLETED
Status Verified Date:
2025-05
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:
None
Brief Summary:
The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM).
Secondary objectives are to further demonstrate the efficacy of fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to fremanezumab.
The total duration of the study is planned to be up to 51 months.
Secondary objectives are to further demonstrate the efficacy of fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to fremanezumab.
The total duration of the study is planned to be up to 51 months.
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-002055-42 | EUDRACT_NUMBER | None | View |