Headache Migraine
Conditions
Interventions
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Adults *18 of age upon entry into screening. - Documented history of migraine (with or without aura) *12 months prior to screening. - *4 and <15 days per month of migraine symptoms (based on ICHD-3 criteria) on average across 3 months prior to screening based on retrospective reporting. -
Exclusion criteria
Exclusion criteria: - Older than 50 years of age at migraine onset. - Lack of efficacy or poor tolerability with > 2 treatments from the following 7 medication categories for prophylactic treatment of migraine: 1: Divalproex sodium, sodium valproate, 2: Topiramate, 3: Beta blocker , 4: Tricyclic antidepressants, 5: Serotonin-norepinephrine reuptake inhibitors, 6: Flunarizine, verapamil, 7: Lisinopril, candesartan - Used a prohibited medication, device, or procedure within 2 months prior to the start of or during baseline or during the treatment period. - Exposure to botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline period, during the baseline period, or treatment period. - Taken the following for any indication in any month during the 2 months prior to the start of the baseline period: - Ergotamines or triptans on * 10 days per month, or - Simple analgesics (non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on * 15 days per month, or - Opioid- or butalbital-containing analgesics on *4 days per month, or - Device, or procedure that potientially may interfere with the intensity or number of migraine days - Previous exposure to erenumab or exposure to any other prophylactic CGRP-targeted therapy (prior to and during the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to demonstrate the superiority of subcutaneous erenumab compared to oral prophylactic(s) on sustained benefit defined as % subjects completing one-year on the randomized treatment and achieving at least a 50% reduction from baseline in monthly migraine days at month 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are the following: Objective 1: To evaluate the effect of erenumab compared to oral prophylactic(s) on overall subject retention defined as % subjects completing study on randomized treatment Objective 2: To evaluate the effect of erenumab compared to oral prophylactic(s) on the change from baseline in monthly migraine days during the treatment period Objective 3: To evaluate the effect of erenumab compared to oral prophylactic(s) on the subject's assessment of the change in clinical status since the start of treatment as measured by the Patients' Global Impression of Change (PGIC) Scale | — |
Countries
Netherlands
Outcome results
None listed