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The Childhood and Adolescent Migraine Prevention Study (CHAMP)

This study has been terminated.
(Interim assessment provided sufficient data to answer study questions)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581281
First Posted: April 20, 2012
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
December 16, 2011
April 20, 2012
November 16, 2016
August 10, 2017
August 10, 2017
June 2012
April 2015   (Final data collection date for primary outcome measure)
Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days [ Time Frame: 4 week baseline period and last 4 weeks of the 24-week trial ]

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.

Reduction in Migraine Frequency (amitriptyline and topiramate) [ Time Frame: 4 week baseline period to last 4 weeks of the 24-week trial ]
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.
Complete list of historical versions of study NCT01581281 on ClinicalTrials.gov Archive Site
  • Change in Absolute Headache Disability Score on PedMIDAS [ Time Frame: baseline and 24 week endpoint ]

    The PedMIDAS scale which evaluated the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions were answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale was administered at baseline (covering the three months prior to enrollment) and at the 24-week endpoint visit (the end of the maintenance period, covering three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this trial. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities. The main outcome measure for this comparison will be the difference in the baseline and endpoint (24 week) PedMIDAS total scores for:

    1. Amitriptyline vs. Placebo
    2. Topiramate vs. Placebo
    3. Amitriptyline vs Topiramate
  • Change in Number of Headache Days [ Time Frame: 4 week baseline period and last 4 weeks of the 24-week trial ]

    This outcomes measure examines whether the rate of absolute number of headache days, per 28 day period, differs between treatment groups over time. This was assessed longitudinally based on the actual number of headache days from the 28 days prior to randomization to the last 28 days of this 24 week trial. The change in absolute headache days was compared between:

    1. Amitriptyline vs. placebo
    2. Topiramate vs. placebo
    3. Amitriptyline vs. Topiramate
  • Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase [ Time Frame: 24 weeks ]
    To assess tolerability, the percentage of subjects who complete the entire 24-week treatment period will be estimated in each of the three groups.
  • Occurrence of Treatment Emergent Serious Adverse Events [ Time Frame: 24 weeks of the trial ]
    To determine if amitriptyline or topiramate differ from placebo on the occurrence of treatment emergent serious adverse events.
  • Reduction in absolute migraine disability score on PedMIDAS [ Time Frame: 4 week baseline period to last 4 weeks of the 24-week trial ]
    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 ]

    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 ]
    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 ]
    To determine if amitriptyline and/or topiramate will result in a decrease in absolute migraine frequency days.
Not Provided
Not Provided
 
The Childhood and Adolescent Migraine Prevention Study
Amitriptyline and Topiramate in the Prevention of Childhood Migraine
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Migraine
  • Migraine Disorders
  • Headache
  • Drug: 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.
  • Drug: 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.
  • Drug: Placebo
    Placebo will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance period.
  • Active Comparator: Amitriptyline
    Drug to be administered twice daily.
    Intervention: Drug: Amitriptyline
  • Active Comparator: Topiramate
    Drug to be administered twice daily.
    Intervention: Drug: Topiramate
  • Placebo Comparator: Placebo
    To be administered twice daily.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
488
January 2016
April 2015   (Final data collection date for primary outcome measure)

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, 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.

Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01581281
CIN-001
1U01NS076788-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: De-identified datasets and associated documentation will be submitted to NINDS for archiving and public access, consistent with current NINDS data sharing policy.
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
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
Children's Hospital Medical Center, Cincinnati
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP