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Completed Phase 3 Interventional Results available

A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

ClinicalTrials.gov ID: NCT04458857

Public ClinicalTrials.gov record NCT04458857. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 7:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04458857
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
235 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 15, 2020 (Actual)
Primary completion
Mar 13, 2024 (Actual)
Completion
Mar 13, 2024 (Actual)
Last update posted
Jun 22, 2026

2020 – 2024

United States locations

U.S. sites
45
U.S. states
26
U.S. cities
41
Facility City State ZIP Site status
Teva Investigational Site 14281 Little Rock Arkansas 72202 —
Teva Investigational Site 14253 Banning California 92220 —
Teva Investigational Site 14370 Loma Linda California 92354 —
Teva Investigational Site 14322 Los Angeles California 90027 —
Teva Investigational Site 14361 Sacramento California 95815 —
Teva Investigational Site 14319 Aurora Colorado 80045 —
Teva Investigational Site 14368 Colorado Springs Colorado 80907 —
Teva Investigational Site 14244 Jacksonville Florida 32256 —
Teva Investigational Site 14325 Miami Florida 33155 —
Teva Investigational Site 14250 West Palm Beach Florida 33407 —
Teva Investigational Site 14255 West Palm Beach Florida 33409 —
Teva Investigational Site 14243 Atlanta Georgia 30328 —
Teva Investigational Site 14258 Savannah Georgia 31406 —
Teva Investigational Site 14263 Hoffman Estates Illinois 60169 —
Teva Investigational Site 14283 Park Ridge Illinois 60068 —
Teva Investigational Site 14245 Wichita Kansas 67206 —
Teva Investigational Site 14327 Louisville Kentucky 40202 —
Teva Investigational Site 14360 Covington Louisiana 70433 —
Teva Investigational Site 14365 Baltimore Maryland 21201 —
Teva Investigational Site 14317 Silver Spring Maryland 26505 —
Teva Investigational Site 14246 Waltham Massachusetts 02451 —
Teva Investigational Site 14251 Ann Arbor Michigan 48104 —
Teva Investigational Site 14270 Minneapolis Minnesota 55402 —
Teva Investigational Site 14376 Ridgeland Mississippi 39157 —
Teva Investigational Site 14256 Bridgeton Missouri 63044-2513 —
Teva Investigational Site 14371 New Brunswick New Jersey 08901 —
Teva Investigational Site 14276 Amherst New York 14226 —
Teva Investigational Site 14377 Durham North Carolina 27710 —
Teva Investigational Site 14248 Raleigh North Carolina 27607 —
Teva Investigational Site 14264 Cincinnati Ohio 45229-3039 —
Teva Investigational Site 14257 Oklahoma City Oklahoma 73112 —
Teva Investigational Site 14275 Oklahoma City Oklahoma 73116 —
Teva Investigational Site 14363 Tulsa Oklahoma 74136 —
Teva Investigational Site 14364 Philadelphia Pennsylvania 19104-4318 —
Teva Investigational Site 14374 Bristol Tennessee 37620 —
Teva Investigational Site 14252 Austin Texas 78731 —
Teva Investigational Site 14273 Austin Texas 78759 —
Teva Investigational Site 14274 Bellaire Texas 77401 —
Teva Investigational Site 14367 Dallas Texas 75235-7701 —
Teva Investigational Site 14312 Houston Texas 77087 —
Teva Investigational Site 14366 San Antonio Texas 78207 —
Teva Investigational Site 14241 San Antonio Texas 78240 —
Teva Investigational Site 14375 Salt Lake City Utah 84109 —
Teva Investigational Site 14323 Norfolk Virginia 23510 —
Teva Investigational Site 14277 Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 44 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04458857, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 22, 2026 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04458857 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →