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

NCT03828539 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 777

Last updated 2021-10-11

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Erenumab

70mg/1mL (70 mg) or 2x70mg/1mL (140 mg) in pre-filled syringe, administered every 4 weeks

DRUG

Topiramate

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.

BIOLOGICAL

Erenumab matching placebo

Erenumab matching placebo pre-filled syringue administered every 4 weeks

DRUG

Topiramate matching placebo

Topiramate matching placebo administered daily

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-22
Primary Completion
2020-07-29
Completion
2020-07-29
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03828539 on ClinicalTrials.gov