The Childhood and Adolescent Migraine Prevention Study

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Migraine, Migraine Disorders, Headache

In brief

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

Key facts

Study ID: NCT01581281
Run by: Children's Hospital Medical Center, Cincinnati
People needed: 488
Starts: 2012-06-01
Expected to finish: 2016-01-01
Last updated by the study team: 2017-08-10

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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)"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.

Where it is running

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

Full record on ClinicalTrials.gov

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