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

Study Overview
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Brief Summary
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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
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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)

Official Title
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Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy; a Real World Prospective Observational Study

Conditions
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Refractory Chronic Migraine

Intervention / Treatment
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* Drug: Erenumab Auto-Injector


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Reduction in monthly migraine days all cohorts at 4 months<br>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) | Drug: Erenumab Auto-Injector<br>* Assess synergy of add on medication to Erenumab<br>* Other names: Botox, and oral migraine preventives;|
| Selection of elegible paitients<br>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. | Drug: Erenumab Auto-Injector<br>* Assess synergy of add on medication to Erenumab<br>* Other names: Botox, and oral migraine preventives;|
| Rate of adverse events related to Erenumab<br>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% | Drug: Erenumab Auto-Injector<br>* Assess synergy of add on medication to Erenumab<br>* Other names: Botox, and oral migraine preventives;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in monthly migraine days | Change in frequency of monthly migraine days | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency of monthly migraine days adding Erenumab to another preventive treatment, | Change in the frequency of monthly migraine days with Botox plus Erenumab, | 5 months | 
| Change in the frequency of monthly migraine days adding Erenumab to another preventive treatment | Change in the freqyency of monthly migraine days with an oral preventive plu erenumab | 5 months | 
| change in frequency of monthly migraine days with Erenumab alone | change in frequency of monthly migraine days without adding another preventive to Erenumab | 5 months |