A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate 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 K.K.0 个研究点目标入组 456 人开始时间: 2020年2月14日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方: Amgen K.K.
入组人数: 456

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 6age old 至 <= 17age old（—）
性别: All

入选标准

•1. 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.
•2. Subject's parent or legal representative has provided written informed consent before initiation of any study specific activities/procedures.
•3. 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 subject self-report or parents' or legal representative's report.
•The following ICHD-3 specifications for pediatric migraine (subjects 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 subjects have facial location of pain, which is called 'facial migraine' in the literature; there is no evidence that these subjects form a separate subgroup of migraine subjects.
•- In young children, photophobia and phonophobia may be inferred from their behavior.
•4. History of less than 15 headache days per month of which greater than or equal to 4 headache days were assessed by the subject as migraine days in each of the 3 months prior to screening.
•Criteria to be assessed prospectively during the 4-week baseline phase and confirmed before randomizing the subject into the DBTP:
•5. Migraine frequency: greater than or equal to 4 and less than 15 migraine days based on the eDiary data during the last 28 days of the baseline if greater than 28 days in duration.
•6. Headache frequency: less than 15 headache days based on the eDiary data during the last 28 days of the baseline phase if greater than 28 days in duration.
•7. Demonstrated at least 80% compliance with the eDiary based on the last 28 days of the baseline period, if greater than 28 days in duration (eg, completing eDiary items for at least 23 out of the last 28 days of the baseline phase).

排除标准

•1. History of cluster headache or hemiplegic migraine headache.
•2. No therapeutic response with greater than 2 of the following 10 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. These medication categories are:
•- Category 1: beta blockers (eg, propranolol, atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, timolol)
•- Category 2: tricyclic antidepressants (eg, amitriptyline, nortriptyline, protriptyline)
•- Category 3: topiramate
•- Category 4: divalproex sodium, sodium valproate
•- Category 5: serotonin-norepinephrine reuptake inhibitors (eg, venlafaxine, desvenlafaxine, duloxetine, milnacipran)
•- Category 6: cyproheptadine
•- Category 7: flunarizine, cinnarizine
•- Category 8: botulinum toxin
•- Category 9: lisinopril/candesartan
•- Category 10: medications targeting the CGRP pathway
•No therapeutic response is defined as no reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally-accepted therapeutic dose(s) based on the investigator's assessment.
•The following scenarios do not constitute lack of therapeutic response:
•- Lack of sustained response to a medication.
•- partial, suboptimal response to a medication
•- failure to tolerate a therapeutic dose.
•3. 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 (with the exception of prescribed medications such as opioids or barbiturates).
•4. Human immunodeficiency virus (HIV) infection by history
•5. History of seizure disorder or other significant neurological disorder other than migraine. Note: a single childhood febrile seizure is not exclusionary.
•6. History of major psychiatric disorder (such as schizophrenia, schizoaffective disorder, bipolar disorder, obsessive-compulsive disorder, or pervasive developmental disorder), or current evidence of major depressive disorder based on a patient health questionnaire-9 modified for adolescents (PHQ-A) score greater than or equal to 10 at screening. Subjects with anxiety disorder and/or mild major depressive disorder (with PHQ-A score <= 9) are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Subjects must have been on a stable dose within the 3 months before the start of the baseline phase.
•7. Use of prohibited medication within 1 month before the start of the baseline phase and/or during the baseline phase
•8. Use of prohibited devices (such as stimulation devices) or procedures (such as acupuncture, biofeedback, relaxation techniques, or psychotherapy) with the goal of preventing migraines, within 3 months before the start of the baseline phase and/or during the baseline phase
•Subjects receiving Cognitive Behavioral Therapy (CBT) are excluded unless they are on a stable, maintenance phase of a CBT program for migraine for at least 3 months before the start of the baseline phase. Subjects undergoing CBT are considered on a stable, maintenance phase if they have undergone greater than or equal 6 weekly or biweekly sessions of CBT administered by adequately trained psychologists and who, for at least 3 months before the start of the baseline phase, only follow booster CBT sessions at a monthly, bimonthly or quarterly frequency.
•Note: Subjects who have discontinued CBT wi

研究者

发起方

Amgen K.K.

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