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Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab — COMIG  

Migraine Clinical Trial

Official title:
A 12-month Prospective, Phase IIIb, Multicenter, Open-label Clinical Trial to Assess Health-related Quality of Life (HRQoL) in Patients With Chronic or High-frequency Episodic Migraine Treated With Erenumab Who Present Associated Comorbidities

Clinical Trial Summary

Migraine is a very common, neurological disorder, characterized by recurrent episodes of headache, potential progression to more frequent and severe attack patterns, and associated symptoms. In Spain, the prevalence rates are 12-13% and in women up to 17-18% Migraine has been shown to largely impair patient's Health-Related Quality of Life (HRQoL), affecting work, household chores, social activities and family life. Recurrent headache attacks and frequently persistent fear and concern about the next attack disrupt the patient's familial, occupational and social life, and reduce his/her expectations for career and financial future. The consequences of this loss of productivity is also shared in his/her private life with their family. For this reason, not only the clinical benefit but other dimensions as HRQoL or work affectation should be added to the study of the benefits of migraine treatment.

Migraine pathophysiology pathways may be shared with other illness, such as fibromyalgia, chronic fatigue or Irritable Bowel Syndrome (IBS) . The purpose of the present clinical trial is to evaluate whether erenumab, at a target dose of 70 mg or 140 mg for a period of 12 months, impacts Health-Related Quality of Life (HRQoL) among patients withchronic migraine (CM) or High-Frequency Episodic Migraine (HFEM) who are affected with at least one comorbidity (fibromyalgia, fatigue and IBS). Data from this study, will provide additional information to help clinicians in treating patients with migraine and other illness.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04114630
Study type Interventional
Source Novartis
Contact
Status Withdrawn
Phase Phase 3
Start date October 30, 2019
Completion date January 7, 2022
View Details
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