CompletedPhase 4

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

Germany777 participantsStarted 2019-02-22

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Documented history of migraine in the 12 months prior to screen
✓. at least 4 days per month of migraine symptoms
✓. \>=80% diary compliance during the Baseline period
✓. Patients must be either naïve or not suitable or have failed previous migraine prophylactic treatments

Exclusion criteria

✕. Older than 50 years of age at migraine onset
✕. Pregnant or nursing
✕. History of cluster or hemiplegic headache
✕. History or evidence of major psychiatric disorder
✕. Score of 19 or higher on Beck Depression Inventory (BDI)

What they're measuring

Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE)

Timeframe: 24 Weeks

Trial details

NCT IDNCT03828539

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-29

Results submitted2021-07-16

View on ClinicalTrials.gov More Migraine trials