ACTIVE_NOT_RECRUITING

Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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])

Quick Facts

Study Start:2019-07-19
Study Completion:2026-10-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03836040

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.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Paradigm Clinical Research Center Inc
San Diego, California, 92108
United States
Childrens Hospital Colorado
Aurora, Colorado, 80045
United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
United States
New England Institute for Clinical Research
Stamford, Connecticut, 06905
United States
Childrens National Health System
Washington, District of Columbia, 20010
United States
Northwest Florida Clinical Research Group Limited Liability Company
Gulf Breeze, Florida, 32561
United States
Nicklaus Childrens Hospital
Miami, Florida, 33155
United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, 33609
United States
TrueBlue Clinical Research
Tampa, Florida, 33612
United States
Premiere Research Institute
West Palm Beach, Florida, 33407
United States
Rare Disease Research Center Pediatrics
Atlanta, Georgia, 30329
United States
CenExel iResearch, LLC
Savannah, Georgia, 31405
United States
Northwestern University
Chicago, Illinois, 60611
United States
Chicago Headache Center and Research Institute
Chicago, Illinois, 60657
United States
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, 46256
United States
University of Maryland, Baltimore
Baltimore, Maryland, 21201
United States
New England Regional Headache Center Inc
Worcester, Massachusetts, 14226
United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104
United States
Clinical Research Institute Inc
Minneapolis, Minnesota, 55402
United States
Childrens Mercy Hospital and Clinics
Kansas City, Missouri, 64108
United States
Mercy Research
Saint Louis, Missouri, 63141
United States
Velocity Clinical Research, Inc
Grand Island, Nebraska, 68803
United States
Dent Neurosciences Research Center
Amherst, New York, 14226
United States
Modern Migraine MD
New York, New York, 10001
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Nationwide Childrens Hospital
Columbus, Ohio, 43205
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, 15236
United States
Palmetto Gastroenterology Clinical Research, LLC
Summerville, South Carolina, 29486
United States
Child Neurology Consultants of Austin
Austin, Texas, 78757
United States
Helios Clinical Research Inc
Burleson, Texas, 76028
United States
Stryde Consulting LLC
Frisco, Texas, 75033
United States
Childrens Specialty Group
Norfolk, Virginia, 23507
United States
Vaught Neurological Services
Crab Orchard, West Virginia, 25827
United States
Marshfield Clinic
Marshfield, Wisconsin, 54449
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-19
Study Completion Date2026-10-13

Study Record Updates

Study Start Date2019-07-19
Study Completion Date2026-10-13

Terms related to this study

Keywords Provided by Researchers

  • Migraine
  • Headache
  • Prevention
  • Pediatric
  • Episodic Migraine

Additional Relevant MeSH Terms

  • Migraine