Study Stopped
Interim assessment provided sufficient data to answer study questions
The Childhood and Adolescent Migraine Prevention Study
CHAMP
Amitriptyline and Topiramate in the Prevention of Childhood Migraine
2 other identifiers
interventional
488
1 country
35
Brief Summary
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2012
Typical duration for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2011
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
August 10, 2017
CompletedAugust 10, 2017
July 1, 2017
2.8 years
December 16, 2011
November 16, 2016
July 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days
The primary endpoint was a ≥ 50% reduction in headache frequency from the 28 days (4 weeks) baseline period prior to randomization to the last 28 days (4 weeks) of the trial. Headache frequency was defined as the number of days with headache for a given four week 28 day (4 week) period. A headache day was defined as any day during which any headache occurs within a 24 hour period, starting and ending at midnight. For each participant, the primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period. Results were compared across the three treatment groups.
4 week baseline period and last 4 weeks of the 24-week trial
Secondary Outcomes (4)
Change in Absolute Headache Disability Score on PedMIDAS
baseline and 24 week endpoint
Change in Number of Headache Days
4 week baseline period and last 4 weeks of the 24-week trial
Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase
24 weeks
Occurrence of Treatment Emergent Serious Adverse Events
24 weeks of the trial
Study Arms (3)
Amitriptyline
ACTIVE COMPARATORDrug to be administered twice daily.
Topiramate
ACTIVE COMPARATORDrug to be administered twice daily.
Placebo
PLACEBO COMPARATORTo be administered twice daily.
Interventions
Amitriptyline will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. The morning dose is a placebo pill. Dosing of amitriptyline will be weight-based.
Topiramate will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. Dosing of topiramate will be weight-based.
Placebo will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance period.
Eligibility Criteria
You may qualify if:
- Migraine with or without aura (International Classification of Headache Disorders, 2nd Edition (ICHD-II) or chronic migraine (ICHD-II revised)
- Migraine frequency based upon prospective headache diary of 28 days must be ≥ 4. Migraine frequency defined as any migraine during one day in the 28 day baseline period (1)
- PedMIDAS Disability Score \> 10, indicating at least mild disruption in daily activities and \< 140, indicating extreme disability that may require more comprehensive, multi-component therapy
- Females or males 8-17 years, inclusive
- Migraine frequency is defined as the period from the onset to the stop time of painful migraine symptoms not to exceed 24 hours with the clock starting at midnight. If painful symptoms last longer than 24 hours, this is considered a new and distinct migraine headache. If painful symptoms recur within 24 hours of initial onset, this is considered part of the initial migraine episode and would be counted as one migraine.
You may not qualify if:
- Continuous migraine defined as an unrelenting headache for a 28 day period
- Weight less than 30 kg or greater than 120 kg
- Unwilling to avoid taking non-specific acute medication such as NSAIDS (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications such as triptans more than 6 times per month
- Currently taking other prophylactic anti-migraine medication within a period equivalent to 2 weeks of that medication before entering the screening phase, or the use of Botulinum toxin (Botox®) within 3 months of entering the screening phase
- Subjects who have previously failed an adequate trial of AMI or TPM for prophylaxis of at least 3 months duration at doses recommended for migraine relief because of lack of efficacy or adverse events(2)
- Current use of disallowed medications/products: opioids, antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, sedatives, tramadol, nutraceuticals, SSRIs, or SSNRIs
- Known history of allergic reaction or anaphylaxis to AMI or TPM
- Abnormal findings on ECG at baseline, particularly lengthening of the QT interval greater than or equal to 450 msec
- Subject is pregnant or has a positive pregnancy test
- Subject is sexually active and not using a medically acceptable form of contraception
- Diagnosis of epilepsy or other neurological diseases
- History of kidney stones
- Inability to swallow pills after using behavioral techniques if indicated between screening visit and baseline visit (3)
- Present psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation) that, in the opinion of the site investigator, would interfere with adherence to study requirements or safe participation in the trial
- Any and all other diagnoses or conditions which in the opinion of the site investigator, that would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study subject
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Phoenix Children's Medical Group
Phoenix, Arizona, 85016, United States
University of California-San Francisco Headache Center
San Francisco, California, 94115, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Atlanta Headache Specialists
Atlanta, Georgia, 30342, United States
Josephson Wallack Munshower Neurology Research
Indianapolis, Indiana, 46237, United States
Children's Mercy Hospital
Kansas City, Kansas, 66160, United States
University of Louisville Health Sciences Center
Louisville, Kentucky, 40292, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Children's Hospital of Boston
Waltham, Massachusetts, 02453, United States
New England Regional Headache Center
Worcester, Massachusetts, 01605, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Saint Louis University
St Louis, Missouri, 63104, United States
University of Nevada
Reno, Nevada, 89502, United States
Dent Neurological Institute
Amherst, New York, 14226, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
The Headache Institute at Roosevelt Hospital
New York, New York, 10019, United States
Schenectady Neurological Constultants, PC
Schenectady, New York, 12308, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
The Children's Hospital, Cleveland Clinic
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Preferred Clinical Research
Pittsburgh, Pennsylvania, 15236, United States
LeBonheur Children's Hospital
Memphis, Tennessee, 38105, United States
Dallas Pediatric Neurology Associates
Dallas, Texas, 75230, United States
Scott and White Healthcare
Temple, Texas, 76508, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84108, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23510, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Related Publications (4)
Reidy BL, Powers SW, Coffey CS, Chamberlin LA, Ecklund DJ, Klingner EA, Yankey JW, Korbee LL, Porter LL, Peugh J, Kabbouche MA, Kacperski J, Hershey AD; CHAMP Investigators. Multimodal Assessment of Medication Adherence Among Youth With Migraine: An Ancillary Study of the CHAMP Trial. J Pediatr Psychol. 2022 Apr 8;47(4):376-387. doi: 10.1093/jpepsy/jsab123.
PMID: 34865085DERIVEDReidy BL, Peugh J, Hershey AD, Coffey CS, Chamberlin LA, Ecklund DJ, Klingner EA, Yankey JW, Korbee LL, Porter LL, Kabbouche MA, Kacperski J, Powers SW. Trajectory of treatment response in the child and adolescent migraine prevention (CHAMP) study: A randomized clinical trial. Cephalalgia. 2022 Jan;42(1):44-52. doi: 10.1177/03331024211033551. Epub 2021 Aug 17.
PMID: 34404270DERIVEDPowers SW, Coffey CS, Chamberlin LA, Ecklund DJ, Klingner EA, Yankey JW, Korbee LL, Porter LL, Hershey AD; CHAMP Investigators. Trial of Amitriptyline, Topiramate, and Placebo for Pediatric Migraine. N Engl J Med. 2017 Jan 12;376(2):115-124. doi: 10.1056/NEJMoa1610384. Epub 2016 Oct 27.
PMID: 27788026DERIVEDHershey AD, Powers SW, Coffey CS, Eklund DD, Chamberlin LA, Korbee LL; CHAMP Study Group. Childhood and Adolescent Migraine Prevention (CHAMP) study: a double-blinded, placebo-controlled, comparative effectiveness study of amitriptyline, topiramate, and placebo in the prevention of childhood and adolescent migraine. Headache. 2013 May;53(5):799-816. doi: 10.1111/head.12105. Epub 2013 Apr 17.
PMID: 23594025DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scott Powers, PhD
- Organization
- Cincinnati Children's Hospital Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Scott W. Powers, PhD
Children's Hospital Medical Center, Cincinnati
- PRINCIPAL INVESTIGATOR
Andrew D. Hershey, MD, PhD
Children's Hospital Medical Center, Cincinnati
- PRINCIPAL INVESTIGATOR
Christopher S. Coffey, PhD
University of Iowa
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2011
First Posted
April 20, 2012
Study Start
June 1, 2012
Primary Completion
April 1, 2015
Study Completion
January 1, 2016
Last Updated
August 10, 2017
Results First Posted
August 10, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will share
De-identified datasets and associated documentation will be submitted to NINDS for archiving and public access, consistent with current NINDS data sharing policy.