The Childhood and Adolescent Migraine Prevention Study (CHAMP)

This study is currently recruiting participants.
Verified February 2014 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01581281
First received: December 16, 2011
Last updated: March 5, 2014
Last verified: February 2014
  Purpose

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.


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: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amitriptyline 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: 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 Drug: Placebo
Placebo will be administered twice daily at home during the 8-week titration period.

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

Contacts
Contact: Leigh Ann Chamberlin, RD, MEd 513-636-9739 leighann.chamberlin@cchmc.org
Contact: Leslie Korbee, BS, SI(ASCP) 513-636-6272 leslie.korbee@cchmc.org

  Show 35 Study Locations
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: March 5, 2014
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:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Amitriptyline
Amitriptyline, perphenazine drug combination
Topiramate
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents

ClinicalTrials.gov processed this record on April 15, 2014