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

Refractory Chronic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152434
• Other study ID #: Erenumab 01
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: November 2019
• Source: Clinique des Céphalées de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: August 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders
• Refractory Chronic Migraine

Intervention

Drug:
• Erenumab Auto-Injector
Assess synergy of add on medication to Erenumab

Locations

Country	Name	City	State
Canada	Guy Pierre Boudreau	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Clinique des Céphalées de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in monthly migraine days	Change in frequency of monthly migraine days	5 months
Secondary	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
Secondary	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
Secondary	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