Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine

Description

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to \<12 years) and adolescents (12 to \<18 years) with episodic migraine. The study hypothesis is that in pediatric participants with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).

Conditions

Migraine

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Study Overview

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Study Details

Study overview

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to \<12 years) and adolescents (12 to \<18 years) with episodic migraine. The study hypothesis is that in pediatric participants with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).

A Phase 3, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Episodic Migraine (OASIS PEDIATRIC [EM])

Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine

Condition
Migraine
Intervention / Treatment

-

Contacts and Locations

San Diego

Paradigm Clinical Research Center Inc, San Diego, California, United States, 92108

Aurora

Childrens Hospital Colorado, Aurora, Colorado, United States, 80045

Colorado Springs

Colorado Springs Neurological Associates, Colorado Springs, Colorado, United States, 80907

Stamford

New England Institute for Clinical Research, Stamford, Connecticut, United States, 06905

Washington

Childrens National Health System, Washington, District of Columbia, United States, 20010

Gulf Breeze

Northwest Florida Clinical Research Group Limited Liability Company, Gulf Breeze, Florida, United States, 32561

Miami

Nicklaus Childrens Hospital, Miami, Florida, United States, 33155

Miami

Nicklaus Childrens Hospital, Miami, Florida, United States, 33155

Tampa

Pediatric Epilepsy and Neurology Specialists, Tampa, Florida, United States, 33609

Tampa

TrueBlue Clinical Research, Tampa, Florida, United States, 33609

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    6 Years to 17 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Amgen,

    MD, STUDY_DIRECTOR, Amgen

    Study Record Dates

    2027-02-10