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NCT04458857 · ClinicalTrials.gov registry record · Phase 3
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
A Phase 3 study of Migraine, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 235
- Enrollment target
- 20
- Study locations
NCT04458857: Completed Phase 3 study of Migraine, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT04458857 is a Phase 3 study of Migraine that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 235 participants, below the 356-participant average among 102 other Migraine trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04458857, a Phase 3 study of Migraine, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 235 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
A migraine day was defined as a day with any of the following: A day (0:00 to 23:59) with at least 2 hours of headache with ≥2 migraine symptom(s) or day (0:00 to 23:59) demonstrating a headache treated with migraine medications (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\], paracetamol etc.), or a headache associated with aura. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with ass
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fremanezumab
Study Locations (20)
California
- Teva Investigational Site 14253 - Banning
- Teva Investigational Site 14370 - Loma Linda
- Teva Investigational Site 14322 - Los Angeles
- Teva Investigational Site 14361 - Sacramento
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
- Teva Investigational Site 14283 - Park Ridge
Maryland
- Teva Investigational Site 14365 - Baltimore
- Teva Investigational Site 14317 - Silver Spring
Arkansas
- Teva Investigational Site 14281 - Little Rock
Kansas
- Teva Investigational Site 14245 - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2020-07-15 |
| Est. Completion | 2024-03-13 |
| Phase | Phase 3 |
What the finished NCT04458857 record still lists
NCT04458857 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 356-participant average among 102 other Migraine trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04458857 names 20 study sites across 10 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT04458857 about?
NCT04458857 is a clinical study titled "A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age". 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 ev...
What is the current status of trial NCT04458857?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2020-07-15. Estimated completion is 2024-03-13.
What conditions does trial NCT04458857 study?
This clinical trial studies the following conditions: Migraine.
What interventions are being tested in trial NCT04458857?
The interventions under investigation include: Placebo (DRUG), Fremanezumab (DRUG).
Who is sponsoring clinical trial NCT04458857?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04458857 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04458857's enrollment target sits among peer trials
235 37th of 102 higher than 66 of 102 other Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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