The Childhood and Adolescent Migraine Prevention Study (CHAMP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01581281
First received: December 16, 2011
Last updated: February 16, 2015
Last verified: February 2015
  Purpose

The purpose of this research study is to test two medicines for migraine prevention in children and adolescents.


Condition Intervention Phase
Migraine
Migraine Disorders
Headache
Drug: Amitriptyline
Drug: Topiramate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Amitriptyline and Topiramate in the Prevention of Childhood Migraine

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Reduction in Migraine Frequency (amitriptyline and topiramate) [ Time Frame: 4 week baseline period to last 4 weeks of the 24-week trial ] [ Designated as safety issue: No ]
    To test if amitriptyline and topiramate are superior to placebo in reducing migraine frequency, as defined by the percentage of subjects with a 50% reduction in the number of migraine days per month, in children and adolescents ages 8-17.


Secondary Outcome Measures:
  • Reduction in absolute migraine disability score on PedMIDAS [ Time Frame: 4 week baseline period to last 4 weeks of the 24-week trial ] [ Designated as safety issue: No ]
    To determine if amitriptyline and/or topiramate will result in a decrease in absolute migraine disability score (measured by PedMIDAS).

  • Safety and tolerability of amitriptyline and topiramate [ Time Frame: 4 week baseline period to last 4 weeks of the 24-week trial ] [ Designated as safety issue: Yes ]

    To determine if amitriptyline and topiramate are well tolerated, and safe for participants and their care givers.

    Tolerability will be measured by a determination of the number of participants who are able to achieve the planned maximum dosage of the active study drugs without enduring dosage limiting side effects.

    Safety will be measured by the quantitative review of adverse events for all three arms of the study in comparison with placebo and the adverse events profiles reported in the package inserts for the study drugs.


  • Occurrence of treatment-emergent serious adverse events [ Time Frame: 4 week baseline period to last 4 weeks of the 24-week trial ] [ Designated as safety issue: Yes ]
    To determine if amitriptyline or topiramate differ from placebo on the occurrence of treatment-emergent serious adverse events.

  • Reduction in absolute migraine frequency days [ Time Frame: 4 week baseline period to last 4 weeks of the 24-week trial ] [ Designated as safety issue: No ]
    To determine if amitriptyline and/or topiramate will result in a decrease in absolute migraine frequency days.


Estimated Enrollment: 675
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amitriptyline
Drug to be administered twice daily.
Drug: Amitriptyline
Amitriptyline will be administered twice daily at home during the 8-week titration period. The morning dose is a placebo pill. Dosing of amitriptyline will be weight-based.
Active Comparator: Topiramate
Drug to be administered twice daily.
Drug: Topiramate
Topiramate will be administered twice daily at home during the 8-week titration period. Dosing of topiramate will be weight-based.
Placebo Comparator: Placebo
To be administered twice daily.
Drug: Placebo
Placebo will be administered twice daily at home during the 8-week titration period.

Detailed Description:

The purpose of this research study is to test two medicines for migraine prevention in children and adolescents. The investigators want to see if amitriptyline and/or topiramate are better than placebo (sugar pill) in reducing headache frequency in children and adolescents ages 8 to 17 with migraines. At this time, there are no FDA approved medicines approved in the US for the prevention treatment of migraine headaches in children and adolescents.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

    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:

  • 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
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581281

  Hide Study Locations
Locations
United States, Arizona
Phoenix Children's Medical Group
Phoenix, Arizona, United States, 85016
United States, California
University of California-San Francisco Headache Center
San Francisco, California, United States, 94115
Stanford Hospital and Clinics
Stanford, California, United States, 94305
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States, 80907
United States, District of Columbia
Children's National Medical Center
Washington DC, District of Columbia, United States, 20010
United States, Florida
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta Headache Specialists
Atlanta, Georgia, United States, 30342
United States, Indiana
Josephson Wallack Munshower Neurology Research
Indianapolis, Indiana, United States, 46237
United States, Kansas
Children's Mercy Hospital
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Louisville Health Sciences Center
Louisville, Kentucky, United States, 40292
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Children's Hospital of Boston
Waltham, Massachusetts, United States, 02453
New England Regional Headache Center
Worcester, Massachusetts, United States, 01605
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Louis University
St. Louis, Missouri, United States, 63104
United States, Nevada
University of Nevada
Reno, Nevada, United States, 89502
United States, New York
Dent Neurological Institute
Amherst, New York, United States, 14226
Winthrop University Hospital
Mineola, New York, United States, 11501
The Headache Institute at Roosevelt Hospital
New York, New York, United States, 10019
Schenectady Neurological Constultants, PC
Schenectady, New York, United States, 12308
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
The Children's Hospital, Cleveland Clinic
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Oklahoma
Oklahoma Health Sciences
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Preferred Clinical Research
Pittsburgh, Pennsylvania, United States, 15236
United States, Tennessee
LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Dallas Pediatric Neurology Associates
Dallas, Texas, United States, 75230
Scott and White Healthcare
Temple, Texas, United States, 76508
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84108
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23510
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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 The University of Iowa
  More Information

No publications provided by Children's Hospital Medical Center, Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01581281     History of Changes
Other Study ID Numbers: CIN-001, 1U01NS076788-01
Study First Received: December 16, 2011
Last Updated: February 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Pediatric
Children
Adolescent
Headache
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Amitriptyline
Amitriptyline, perphenazine drug combination
Topiramate
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Analgesics, Non-Narcotic
Anti-Obesity Agents
Anticonvulsants
Antidepressive Agents
Antidepressive Agents, Tricyclic
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Psychotropic Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on July 01, 2015