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Supported by evidence-based practice and validated methodologies, the International Headache Society (IHS) and regulatory bodies published a new series of recommendations intended to guide the design, conduct, and reporting of well-controlled trials of preventive treatment of migraine in children and adolescents. This report was published in Cephalalgia.
The investigators developed these recommendations as an outgrowth of the preventive trial guidelines for adults and addressed major issues specific to clinical trials in children and adolescents with migraine. Recommendations were the product of consultations with members of the Clinical Trials and the Child and Adolescent Standing Committees, roundtable discussions with stakeholders (lay people and pharmaceutical professionals), and open consultation with IHS members.
Recommendations for Participants
Selection
Carefully defined inclusion and exclusion criteria are recommended for the appropriate identification of participants. Criteria should specify the diagnoses, demographic features, concomitant health conditions, and treatments of the population to be studied.
Diagnosis
Diagnosis of migraine types and subtypes should follow the most recent version of the International Classification of Headache Disorders (ICHD), which distinguishes specific features of pediatric migraine, including shorter duration, frontotemporal location, and parental observation allowance. The investigators note that it may be difficult to recruit children aged under 12 years for studies on chronic migraine as no reliable data are available on the prevalence of chronic migraine in children. If medication-overuse headache is included in clinical trials of children and adolescents, the pattern of overuse must remain stable through screening, baseline, and treatment phases. Finally, patients with missing criteria to fulfill a defined migraine type or subtype may still be included in chronic migraine trials if they meet the ICHD criteria for chronic migraine.
History of Migraine
Participants should report the presence of recurrent migraine headache for at least 6 months prior to trial inclusion, ensuring its primary nature rather than as a migraine variant, which may initially occur in children and adolescents.
Age at Onset
The IHS recommends accurately recording the age of migraine onset to assure a stable history of primary headache disorder; it is important to note that the initial presentation of migraine in young children may be a variant.
Age at Entry
Clinical trial designs should assure adequate age stratification, defining children as participants aged 6 to 11 years and adolescents as participants aged 12 to 17 years.
Enrollment
Participants enrolled in clinical trials must fulfill all predefined eligibility criteria, which should be documented at baseline and confirmed prior to randomization. The guidelines further limit a participant’s enrollment to 1 clinical trial at a time. Enrolled participants and their parents or guardians should be given clear information regarding the trial purpose, their role in its conduct, and the risks they will assume.
Sex
Adolescent women who are pregnant, may become pregnant, or are breastfeeding should be excluded from participation in a clinical trial; adolescent women included in a trial should adhere to effective contraceptive measures throughout the trial duration.
This article originally appeared on Neurology Advisor
