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OpenTrials
Completed

NCT Number: NCT04152434

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

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

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guy Pierre Boudreau

Montreal, Quebec, H2W 1V1, Canada

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erenumab Auto-Injector

Drug

Assess synergy of add on medication to Erenumab

Other names: Botox, and oral migraine preventives

Primary outcomes

  1. Change in monthly migraine days

    Time frame: 5 months

    Change in frequency of monthly migraine days

Secondary outcomes

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

    Time frame: 5 months

    Change in the frequency of monthly migraine days with Botox plus Erenumab,

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

    Time frame: 5 months

    Change in the freqyency of monthly migraine days with an oral preventive plu erenumab

  3. change in frequency of monthly migraine days with Erenumab alone

    Time frame: 5 months

    change in frequency of monthly migraine days without adding another preventive to Erenumab

Sponsors and collaborators

Lead sponsor

Clinique des Céphalées de Montréal

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 5, 2019
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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