Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy
- Registration Number
- NCT04152434
- Lead Sponsor
- Clinique des Céphalées de Montréal
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
- chronic migraineurs with failure to more than 3 preventive treatments
- Naive to anti CGRP monclonal antibodies
- episodic migraineurs,
- Other headache types
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Reduction in monthly migraine days all cohorts at 4 months Erenumab Auto-Injector 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) Selection of elegible paitients Erenumab Auto-Injector 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. Rate of adverse events related to Erenumab Erenumab Auto-Injector 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%
- Primary Outcome Measures
Name Time Method Change in monthly migraine days 5 months Change in frequency of monthly migraine days
- Secondary Outcome Measures
Name Time Method Change in frequency of monthly migraine days adding Erenumab to another preventive treatment, 5 months Change in the frequency of monthly migraine days with Botox plus Erenumab,
Change in the frequency of monthly migraine days adding Erenumab to another preventive treatment 5 months Change in the freqyency of monthly migraine days with an oral preventive plu erenumab
change in frequency of monthly migraine days with Erenumab alone 5 months change in frequency of monthly migraine days without adding another preventive to Erenumab
Trial Locations
- Locations (1)
Guy Pierre Boudreau
🇨🇦Montreal, Quebec, Canada