Overview

Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine

Status:
Completed

Trial end date:
2020-07-29

Target enrollment:
0

Participant gender:
All

Summary

This study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind, double-dummy design in adult patients with episodic migraine and chronic migraine, who had to be either naïve or not suitable for or could have failed up to three prophylactic treatments out of: propranolol/metoprolol, amitriptyline, flunarizine. Patients were stratified into groups according to their number of migraine days during the baseline period.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Antibodies, Monoclonal
Erenumab
Topiramate

Criteria

Key Inclusion Criteria:

1. Documented history of migraine in the 12 months prior to screen

2. at least 4 days per month of migraine symptoms

3. >=80% diary compliance during the Baseline period

4. Patients must be either naïve or not suitable or have failed previous migraine
prophylactic treatments

Key Exclusion Criteria:

1. Older than 50 years of age at migraine onset

2. Pregnant or nursing

3. History of cluster or hemiplegic headache

4. History or evidence of major psychiatric disorder

5. Score of 19 or higher on Beck Depression Inventory (BDI)