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

Novartis

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Biological: Erenumab; Drug: Topiramate matching placebo; Drug: Topiramate; Biological: Erenumab matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03828539

CAMG334ADE01

2018-000943-15 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

All patients completing the Baseline period and fulfilling baseline eligibility criteria were invited to participate to the Double-blind, double-dummy Treatment Epoch (DBTE, 24 weeks) .

Eligible patients were randomized to one of two treatment arms. DBTE started with a titration phase for topiramate of a maximum of 6 weeks to determine the maximal tolerated dose and aimed to reach the recommended treatment dose of 100 mg according to the German SmPC. After the titration phase, maintenance phase started (18 weeks). Topiramate dose had to be maintained until the end of the DBTE. Erenumab dose at beginning of the DBTE was determined patient individually by the investigator based on the guidance provided in the SmPC and was either 70 mg or 140 mg. Dose escalation from 70 mg to 140 mg in case of insufficient response was considered at anytime during the DBTE.

Dose reduction of topiramate and erenumab was not allowed during DBTE (Week 0 to Week 24). After Week 24 or if the patient discontinued study drug, a one week double-blind taper off phase followed to ensure proper down titration for topiramate. At the end of the DBTE (24 weeks) the final assessment occurred to address the objectives.

A Follow-Up Visit 4 weeks after last study visit (or 8 weeks after last IMP injection for discontinued patients) was required as part of routine safety monitoring. The primary analysis was triggered when all patients had completed their respective last visit of the DBTE.

The End of study occurred when the last patient completed last visit (LPLV).

Enrollment: 777 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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777 participants in 2 patient groups

Erenumab

Experimental group

Description:

70 mg and 140 mg Erenumab

Treatment:

Biological: Erenumab matching placebo

Biological: Erenumab

Topiramate

Active Comparator group

Description:

Topiramate in the highest tolerated dose (50 - 100 mg/day)

Treatment:

Drug: Topiramate

Drug: Topiramate matching placebo