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

NCT04152434 | Completed

• 1 other identifier: Erenumab 01
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

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

Conditions

Refractory Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• Change in monthly migraine days

  Change in frequency of monthly migraine days

  5 months

Secondary Outcomes (3)

• Change in frequency of monthly migraine days adding Erenumab to another preventive treatment,

  5 months

• Change in the frequency of monthly migraine days adding Erenumab to another preventive treatment

  5 months

• change in frequency of monthly migraine days with Erenumab alone

  5 months

Study Arms (3)

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

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

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

Interventions

Erenumab Auto-Injector DRUG

Assess synergy of add on medication to Erenumab

Also known as: Botox, and oral migraine preventives

Rate of adverse events related to Erenumab; Reduction in monthly migraine days all cohorts at 4 months; Selection of elegible paitients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• episodic migraineurs,
• Other headache types

Sponsors & Collaborators

• Clinique des Céphalées de Montréal: lead

Study Sites (1)

Guy Pierre Boudreau

Montreal, Quebec, H2W 1V1, Canada

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Guy P Boudreau, md

  Clinique des Céphalées de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, fellow in headache medecine

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 5, 2019
• Study Start: April 1, 2019
• Primary Completion: July 30, 2019
• Study Completion: August 30, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)