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

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

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

Study Overview

• Status: Completed
• Conditions: Refractory Chronic Migraine
• Intervention / Treatment: Drug: Erenumab Auto-Injector

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)

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1V1
      • Guy Pierre Boudreau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with more than 15 migraine days per month, receiving Botox, or an oral preventive treatment, or without any preventive therapy. Have failed more than 3 preventive treatments previously

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Drug: Erenumab Auto-Injector; Assess synergy of add on medication to Erenumab; Other Names: Botox, and oral migraine preventives
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.	Drug: Erenumab Auto-Injector; Assess synergy of add on medication to Erenumab; Other Names: Botox, and oral migraine preventives
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%	Drug: Erenumab Auto-Injector; Assess synergy of add on medication to Erenumab; Other Names: Botox, and oral migraine preventives

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinique des Céphalées de Montréal
• Investigators: Principal Investigator: Guy P Boudreau, md, Clinique des Céphalées de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Calcitonin Gene-Related Peptide Receptor Antagonists; Erenumab
• Other Study ID Numbers: Erenumab 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No