Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
CompletedPhase 4NCT03828539
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Head-to-head Study of Erenumab Against topiRamate-a Double-blind, Double Dummy Migraine Study to Assess Tolerability and Efficacy in a patiEnt -Centered Setting
- Conditions
- Interventions
- Biological: Erenumab
- Drug: Topiramate
- Biological: Erenumab matching placebo
- Drug: Topiramate matching placebo
- Sponsor
- Novartis Pharmaceuticals
- Organization
- Novartis
- Start date
- 2019-02-22
- Primary completion
- 2020-07-29
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Germany
- Total sites listed
- 79
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03828539