Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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).
    

Intervention name(s): Erenumab; Topiramate; Erenumab matching placebo; Topiramate matching placebo
Intervention type(s): Biological; Drug; Biological; Drug
Intervention description(s): 70mg/1mL (70 mg) or 2x70mg/1mL (140 mg) in pre-filled syringe, administered every 4 weeks; Film-coated tablet taken orally:
25 mg administered once daily (first week of titration phase). After the first week, titration was done according to the summary of product characteristics (SmPC) in 25 mg increments each week and aimed to reach the recommended daily treatment dose of 100 mg (50/75/100 mg). 50/75/100 mg were administered twice daily during titration phase and maintenance phase.; Erenumab matching placebo pre-filled syringue administered every 4 weeks; Topiramate matching placebo administered daily
Other intervention name(s): AMG334; Topamax
Intervention MeSH terms: Topiramate; Erenumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Migraine; Episodic migraine; Chronic migraine; Headache; erenumab; topiramate; CAMG 334; Calcitonin Gene-related Peptide; CGRP; CGRP receptor agonist; monoclonal antibody; treatment failure