Migraine prophylaxis MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Aimovig
Product Code: AMG334
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ERENUMAB
CAS Number: 1582205-90-0
Current Sponsor code: AMG334
Other descriptive name: AMG334
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Documented history of migraine (with or without aura) for =12 months prior to screening according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) - = 4 migraine days per month (based on ICHD-3 criteria) during baseline confirmed by eDiary - Patients must be either naïve or not suitable for or have failed up to three prophylactic treatments out of: propranolol/metoprolol, amitriptyline, flunarizine Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 750 F.1.3 Elderly (>=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 - Unable to differentiate migraine from other headaches - History of cluster headache or hemiplegic migraine headache - Patients who have already been treated with topiramate, valproate or onabotulinumtoxin A - Any previous use of a prophylactic migraine medication targeting the CGRP pathway - Use of a prophylactic migraine medication within 5 half-lives, or a device or procedure within 1 month prior to the start of the baseline phase or during the baseline phase - Use of the following for any indication in the 1 month prior to the start of the baseline phase or during the baseline phase: opioid- or butalbital-containing analgesics =4 days/month Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the tolerability of 70 mg and 140 mg erenumab compared to topiramate in the highest tolerated dose as assessed by the rate of patients discontinuing treatment due to AE during the double-blind epoch of the study.;Secondary Objective: To evaluate the effect of of 70 mg and 140 mg erenumab compared to topiramate in the highest tolerated dose on the proportion of patients with at least 50% reduction from baseline in monthly migraine days.;Primary end point(s): Discontinuation of treatment due to AE during the double-blind epoch of the study.;Timepoint(s) of evaluation of this end point: Ongoing basis during the double-blind epoch of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Achieving at least a 50% reduction from baseline in MMD over the last 3 months (months 4, 5, and 6) of the double-blind epoch.;Timepoint(s) of evaluation of this end point: End of double-blind epoch | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed