Migraine prevention MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: AIMOVIG
Product Name: AIMOVIG
Product Code: AMG334
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Older than 50 years of age at migraine onset. - Failed more than 2 prior migraine prophylaxis (approved) treatments - 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 - 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 |
|---|---|
| Main Objective: 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 Objective: -To evaluate the effect of erenumab compared to oral prophylactic(s) on overall subject retention defined as % subjects completing study on randomized treatment -To evaluate the effect of erenumab compared to oral prophylactic(s) on the change from baseline in monthly migraine days during the treatment period -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 ; Primary end point(s): Proportion of subjects who complete initially assigned treatment and achieve at least 50% reduction from baseline in monthly migraine days at Month 12 ;Timepoint(s) of evaluation of this end point: at Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Proportion of subjects completing the study at Month 12 on the randomized treatment -Cumulative average change from baseline on the monthly migraine days during the treatment period (Months 1-12) -Proportion of responders as measured by PGIC at month 12 on the randomized treatment ;Timepoint(s) of evaluation of this end point: at Month 12 | — |
Countries
Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, Poland, Portugal, Slovakia, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed