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NCT04530110 · ClinicalTrials.gov registry record · Phase 3
A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
A Phase 3 study of Migraine, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 506
- Enrollment target
- 20
- Study locations
NCT04530110 is a Phase 3 study of Migraine that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 506 participants, above the 353-participant average among 102 other Migraine trials with a reported enrollment target (43% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT04530110, a Phase 3 study of Migraine, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 506 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Fremanezumab
Study Locations (20)
Florida
- Teva Investigational Site 14244 - Jacksonville
- Teva Investigational Site 14325 - Miami
- Teva Investigational Site 14250 - West Palm Beach
- Teva Investigational Site 14255 - West Palm Beach
Colorado
- Teva Investigational Site 14319 - Aurora
- Teva Investigational Site 14368 - Colorado Springs
Georgia
- Teva Investigational Site 14243 - Atlanta
- Teva Investigational Site 14258 - Savannah
Illinois
- Teva Investigational Site 14263 - Hoffman Estates
Kansas
- Teva Investigational Site 14245 - Wichita
Kentucky
- Teva Investigational Site 14327 - Louisville
Louisiana
- Teva Investigational Site 14360 - Covington
Maryland
- Teva Investigational Site 14365 - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 506 participants |
| Start Date | 2020-09-16 |
| Est. Completion | 2025-12-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04530110
The ClinicalTrials.gov registry entry for NCT04530110 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 506 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 353-participant average among 102 other Migraine trials with a reported enrollment target (43% higher). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 1 intervention - of which Fremanezumab is the first listed.
NCT04530110 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, Colorado, Georgia.
Frequently Asked Questions
What is clinical trial NCT04530110 about?
NCT04530110 is a clinical study titled "A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents". 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 effica...
What is the current status of trial NCT04530110?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 506 participants. The study started on 2020-09-16. Estimated completion is 2025-12-22.
What conditions does trial NCT04530110 study?
This clinical trial studies the following conditions: Migraine.
What interventions are being tested in trial NCT04530110?
The interventions under investigation include: Fremanezumab (DRUG).
Who is sponsoring clinical trial NCT04530110?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04530110 being conducted?
This trial has 20 study locations across Colorado, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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