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Clinical Trials/EUCTR2017-002397-39-DE
EUCTR2017-002397-39-DE
Active, not recruiting
Phase 1

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study toEvaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Episodic Migraine (OASIS PEDIATRIC [EM])

Amgen Inc.0 sites456 target enrollmentMarch 27, 2019
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ConditionsEpisodic migraineMedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsAimovig

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Episodic migraine
Sponsor
Amgen Inc.
Enrollment
456
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 27, 2019
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Amgen Inc.

Eligibility Criteria

Inclusion Criteria

  • •101 Children (6 to \< 12 years of age) or adolescent (12 to \< 18 years of age) at the
  • •time of signing, if developmentally appropriate, the formal assent to participate to the study.
  • •102 Subject’s parent or legal representative has provided written informed consent before initiation of any study\-specific activities/procedures.
  • •103 History of migraine (with or without aura) for \= 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 subject self\-report or parents' or legal
  • •representative's report.
  • •The following ICHD\-3 specifications for pediatric migraine (subjects
  • •aged \< 18 years), should be considered for the diagnosis of migraine:

Exclusion Criteria

  • •201 History of cluster headache or hemiplegic migraine headache.
  • •202 No therapeutic response with \> 2 of the following 10 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial
  • •203 Malignancy within 5 years before screening.
  • •204 History of suicidal behavior or the subject is at risk of self\-harm or harm to others as evidenced by endorsement of items 4 or 5 on the pediatric Columbia\-suicide Severity Rating Scale (C\-SSRS) assessed at screening.
  • •205 Evidence of drug or alcohol abuse or dependence within 12 months before
  • •screening, based on medical records, subject self\-report, or positive urine drug
  • •test performed during screening
  • •206 Human immunodeficiency virus (HIV) infection by history.
  • •207 History of seizure disorder or other significant neurological disorder other than migraine. Note: a single childhood febrile seizure is not exclusionary.
  • •208 History of major psychiatric disorder

Outcomes

Primary Outcomes

Not specified

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