Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine (NCT03836040) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine
United States457 participantsStarted 2019-07-19
Plain-language summary
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to \<12 years) and adolescents (12 to \<18 years) with episodic migraine. The study hypothesis is that in pediatric participants with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).
Who can participate
Age range6 Years – 17 Years
SexALL
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* Inclusion Criteria
* Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study.
* Participant's parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures.
* History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) based on medical records and/or participant self-report or parents' or legal representative's report.
* The following ICHD-3 specifications for pediatric migraine (participants aged less than 18 years), should be considered for the diagnosis of migraine:
* Attacks may last 2 to 72 hours.
* Migraine headache is more often bilateral than in adults; unilateral pain usually emerges in late adolescence or early adult life.
* Migraine headache is usually frontotemporal. Occipital headache in children is rare and calls for diagnostic caution.
* A subset of otherwise typical participants have facial location of pain, which is called 'facial migraine' in the literature; there is no evidence that these participants form a separate subgroup of migraine participants.
* In young children, photophobia and phonophobia may be inferred from their behavior.
* History of less than 15 headache days…
What they're measuring
1
Change from baseline in MMDs
Timeframe: Baseline through week 12 of the double blind treatment phase