Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
- Conditions
- Chronic migraineMedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-002399-23-GB
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 286
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 based on medical records and/or subject self-report or parents’ or legal representative’s report
104 History of < 15 headache days per month of which = 8 headache days were
assessed by the subject as migraine days per month in each of the 3 months
prior to screening
105 Migraine frequency: = 8 migraine days during the baseline phase based on the eDiary calculations.
106 Headache frequency of = 15 headache days during the baseline phase based on the eDiary calculations.
107 Demonstrated at least 80% compliance with the eDiary (eg, completing eDiary items for at least 23 out of 28 days during the baseline phase).
Are the trial subjects under 18? yes
Number of subjects for this age range: 286
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
201 History of cluster headache or hemiplegic migraine headache.
202 Chronic migraine with continuous pain, in which the subject does not have any pain free periods (of any duration) during the 1 month prior to screening
203 No therapeutic response with > 3 of the following 10 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial.
204 Malignancy within 5 years before screening.
205 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 C-SSRS assessed at
screening.
206 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).
207 Human immunodeficiency virus (HIV) infection by history.
208 History of seizure disorder or other significant neurological disorder other than migraine. Note: a single childhood febrile seizure is not exclusionary.
209 History of major psychiatric disorder
210 Use of a prohibited medication within 1 month before the start of the baseline phase and/or during the baseline phase
211 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
212 Received botulinum toxin in the head and/or neck region within 4 months before the start of the baseline phase or during the baseline phase
213 Received medication targeting the CGRP pathway within 4 months before the start of the baseline phase or during the baseline phase
214 Taken the following for any indication in any month during the 2 months before the start of the baseline phase:
? Opioid or butalbital-containing analgesics on = 4 days per month.
215 Currently receiving treatment in another investigational device or drug study, or less than 90 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded
216 Subject has clinically significant vital signs, laboratory results, or ECG
abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation.
217 Hepatic disease by history or total bilirubin (TBL) = 2.0 x upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3.0 x ULN, as assessed by the central laboratory at initial screening.
218 Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during the study and for an additional 16 weeks after the last dose of investigational product. (Females of childbearing potential should only be included in the study after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test.)
219 Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product. Refer to Appendix 5 for additional contraceptive information.
220 Subject has known sensitivity to any of the products or components to be
administered during dosing
221 Subject likely to not be a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method