Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04530110
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-08
First Post:
2020-08-24
Brief Title:
A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
Sponsor:
Teva Branded Pharmaceutical Products RD Inc
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Multicenter Open-Label Study Evaluating the Long-Term Safety Tolerability and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
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 long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age inclusive at enrollment in the pivotal study
Secondary objectives are to evaluate the efficacy of subcutaneous fremanezumab in pediatric participants with migraine and to evaluate the immunogenicity of fremanezumab and the impact of ADAs on clinical outcomes in pediatric participants exposed to fremanezumab
The total duration of the study is planned to be up to 84 months
Secondary objectives are to evaluate the efficacy of subcutaneous fremanezumab in pediatric participants with migraine and to evaluate the immunogenicity of fremanezumab and the impact of ADAs on clinical outcomes in pediatric participants exposed to fremanezumab
The total duration of the study is planned to be up to 84 months
Detailed Description:
The study population will be composed of 3 subgroups of participants as follows
Participants rolling over from the pivotal Phase 3 pediatric efficacy studies Studies TV48125-CNS-30082 and TV48125-CNS-30083
Participants rolling over from the Phase 1 pediatric pharmacokinetic study Study TV48125-CNS-10141
Participants rolling over from the pivotal Phase 3 pediatric efficacy studies Studies TV48125-CNS-30082 and TV48125-CNS-30083 for safety follow-up and antidrug antibody ADA evaluation only
Participants rolling over from the pivotal Phase 3 pediatric efficacy studies Studies TV48125-CNS-30082 and TV48125-CNS-30083
Participants rolling over from the Phase 1 pediatric pharmacokinetic study Study TV48125-CNS-10141
Participants rolling over from the pivotal Phase 3 pediatric efficacy studies Studies TV48125-CNS-30082 and TV48125-CNS-30083 for safety follow-up and antidrug antibody ADA evaluation only
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 |
|---|---|---|---|
| 2019-002056-16 | EUDRACT_NUMBER | None | None |