Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy

NCT ID: NCT04152434

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-08-30

Brief Summary

Treatment of chronic migraineurs who have failed more than 3 preventive drugs with Erenumab alone, to reduce frequency of monthly migraine days or as an add on therapy

Detailed Description

The investigators treated chronic migraineurs that have failed more than 3 preventive drugs with Erenumab alone or as an add on therapy to: Reduce the frequency of monthly migraine days, to evaluate If the add on of Erenumab to another preventive therapy is superior to Erenumab alone, and assess all adverse events related to the use of Erenumab.

Migraineurs with 15-30 migraie days per month at baseline were clustered in 3 categories. Failure of Erenumab was defined as no improvement in the frequency of monthly migraine days. Group I: no preventive therapy, prior to the start of Erenumab. (No botox cohort). Group II: on Botulinum Toxin A (Botox), prior to the add on therapy with Erenumab. (Botox cohort).Group III: on an oral preventive drug, prior to the add on therapy with Erenumab. (No Botox cohort)

Conditions

Refractory Chronic Migraine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Reduction in monthly migraine days all cohorts at 4 months

Migraineurs with 15-30 headache days per month at baseline were clustered in 3 categories. Failure of Erenumab was defined as no improvement in the frequency of monthly headache days. Group I: no preventive therapy, prior to the start of Erenumab. (No botox cohort). Group II: on Botulinum Toxin A (Botox), prior to the add on therapy with Erenumab. (Botox cohort).Group III: on an oral preventive drug, prior to the add on therapy with Erenumab. (No Botox cohort)

Erenumab Auto-Injector

Intervention Type: DRUG

Assess synergy of add on medication to Erenumab

Selection of elegible paitients

A total of 158 patients were involved in this study. 118 patients (75%), received Erenumab 140 mg., and 40 patients (25%) received 70 mg. In the Botox cohort, of 650 patients, 90 (13%) patients were eligible. In the no Botox cohort, 533 patients, 83 (15%) patients were eligible.

Erenumab Auto-Injector

Intervention Type: DRUG

Assess synergy of add on medication to Erenumab

Rate of adverse events related to Erenumab

72 adverse events were experienced during the 4 months of treatment, mostly with the 140 mg. dose. The most frequent were: constipation 34%, fatigue 19%, itching 7.5%, muscle cramps 6.3%, increased headache 4.4%, rhinitis 4.4%, injection site discomfort 3.7%, lack of energy 3.1%

Erenumab Auto-Injector

Intervention Type: DRUG

Assess synergy of add on medication to Erenumab

Interventions

Erenumab Auto-Injector

Assess synergy of add on medication to Erenumab

Intervention Type: DRUG

Other Intervention Names

Botox, and oral migraine preventives

Eligibility Criteria

Inclusion Criteria

• chronic migraineurs with failure to more than 3 preventive treatments
• Naive to anti CGRP monclonal antibodies

Exclusion Criteria

• episodic migraineurs,
• Other headache types

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique des Céphalées de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Guy Pierre Boudreau md

Medical Doctor, fellow in headache medecine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guy P Boudreau, md

Role: PRINCIPAL_INVESTIGATOR

Clinique des Céphalées de Montréal

Locations

Guy Pierre Boudreau

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

Erenumab 01

Identifier Type: -

Identifier Source: org_study_id