Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
488 participants
INTERVENTIONAL
2012-06-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Amitriptyline
Drug to be administered twice daily.
Amitriptyline
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
Drug to be administered twice daily.
Topiramate
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
To be administered twice daily.
Placebo
Placebo will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance period.
Interventions
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Amitriptyline
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
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
Placebo will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance period.
Eligibility Criteria
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Inclusion Criteria
* 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
1. 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.
Exclusion Criteria
* 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)"Previously failed an adequate trial of AMI or TPM" is defined as: dosage of 1mg/kg/day of AMI or 2 mg/kg/day of TPM; trial of at least 3 months duration; efficacy of having at least a 50% decrease in migraine frequency in response to drug therapy; or unable to tolerate taking the medication due to treatment-related side effects.
(3)Subjects who cannot swallow pills at the time of the screening visit will be given a training session using behavioral techniques. Upon return for baseline visit, if the subject continues to be unable to swallow pills, the subject will be excluded from the study.
8 Years
17 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Scott W. Powers, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Andrew D. Hershey, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Christopher S. Coffey, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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Phoenix Children's Medical Group
Phoenix, Arizona, United States
University of California-San Francisco Headache Center
San Francisco, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Atlanta Headache Specialists
Atlanta, Georgia, United States
Josephson Wallack Munshower Neurology Research
Indianapolis, Indiana, United States
Children's Mercy Hospital
Kansas City, Kansas, United States
University of Louisville Health Sciences Center
Louisville, Kentucky, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Children's Hospital of Boston
Waltham, Massachusetts, United States
New England Regional Headache Center
Worcester, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
University of Nevada
Reno, Nevada, United States
Dent Neurological Institute
Amherst, New York, United States
Winthrop University Hospital
Mineola, New York, United States
The Headache Institute at Roosevelt Hospital
New York, New York, United States
Schenectady Neurological Constultants, PC
Schenectady, New York, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Children's Hospital, Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oklahoma Health Sciences
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Preferred Clinical Research
Pittsburgh, Pennsylvania, United States
LeBonheur Children's Hospital
Memphis, Tennessee, United States
Dallas Pediatric Neurology Associates
Dallas, Texas, United States
Scott and White Healthcare
Temple, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Countries
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References
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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.
Reidy 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.
Powers 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.
Hershey 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.
Other Identifiers
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CIN-001
Identifier Type: -
Identifier Source: org_study_id
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