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

Clinique des Céphalées de Montréal

Status: Completed

Conditions: Refractory Chronic Migraine

Treatments: Drug: Erenumab Auto-Injector

Study type: Observational

Funder types: Other

Identifiers

NCT04152434

Erenumab 01

Details and patient eligibility

About

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

Full 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)

Enrollment: 158 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

158 participants in 3 patient groups

Reduction in monthly migraine days all cohorts at 4 months

Description:

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)

Treatment:

Drug: Erenumab Auto-Injector

Selection of elegible paitients

Description:

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.

Treatment:

Drug: Erenumab Auto-Injector

Rate of adverse events related to Erenumab

Description:

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%

Treatment:

Drug: Erenumab Auto-Injector