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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04458857
The ClinicalTrials.gov registry entry for NCT04458857 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 356-participant average among 102 other Migraine trials with a reported enrollment target (34% lower). 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 2 interventions - of which Placebo is the first listed.
NCT04458857 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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