Migraine
Conditions
Interventions
- Experimental: Dose level 1
Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled underthe original protocol or protocol amendment
Sponsors
Amgen K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Participant'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 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. 4. History of less than 15 headache days per month of which greater than or equal to 4 headache days were assessed by the participant 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 participant 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 phase 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).
Exclusion criteria
Exclusion criteria: 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, participant 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. Participants 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. Participant 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 Participants 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. Participants 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: Participants wh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in MMDs [Time Frame: Baseline through week 12 of the double blind treatment phase] To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in monthly headache days from baseline [Time Frame: Baseline through week 12 of the double blind treatment phase] To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly headache days to week 9 through week 12 (month 3) of the DBTP 2. Proportion of participants with at least 50% reduction in MMDs from baseline [Time Frame: Baseline through week 12 of the double blind treatment phase] To evaluate the effect of erenumab compared with placebo on the proportion of participants with at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the DBTP 3. Change in MMDs from baseline to the average of the first 3 months [Time Frame: Baseline through week 12 of the double blind treatment phase] To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the first 3 months (week 1 through week 12) of the DBTP 4. Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale) [Time Frame: Baseline through week 12 of the double blind treatment phase] To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly average severity of migraine attacks to week 9 through week 12 (month 3) of the DBTP. This will be measured in a daily electronic diary (eDiary) with a visual analogue scale. 5. Change from baseline in migraine-related disability and productivity [Time Frame: Baseline through week 12 of the double blind treatment phase] To evaluate the effect of erenumab compared with placebo on the change from baseline in migraine-related disability and productivity as measured by the modified PedMIDAS to week 9 through week 12 (month 3) of the DBTP. 6. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to week 80] Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred aft | — |
Countries
Belgium, Canada, Colombia, Finland, Germany, Hungary, Italy, Poland, Portugal, Puerto Rico, Russian Federation, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactContact Local
Amgen K.K.
Outcome results
None listed