Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab
Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab
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.
Inclusion Criteria: key inclusion citeria

 During the Screening Epoch:

 1. Signed informed consent must be obtained prior to participation in the study.

 2. Adults ≥18 years of age upon entry into screening.

 3. Patient diagnosed with chronic and high -frequency episodic migraine (with or without
 aura) for at least 1 year prior to screening according to the International
 Classification of Headache Disorders-3rd Edition (ICHD-3).

 4. Patient with a documented diagnosis in clinical history of one or more of the
 following comorbidities: chronic fatigue, fibromyalgia and/or IBS.

 5. Patients previously treated with other monoclonal antibodies for migraine can be
 included if the appropriate washout period according to product half-life has been
 done for each monoclonal antibody.

 During the Baseline Epoch:

 1. Migraine frequency of ≥ 10 migraine days during the Baseline Epoch, confirmed by the
 eDiary.

 2. ≥ 80% eDiary compliance during the Baseline Epoch.

 Exclusion Criteria: Key Exclusion criteria

 1. Older than 50 years of age at migraine onset.

 2. Unable to differentiate migraine from other headaches.

 3. History of cluster headache or hemiplegic migraine headache.

 4. Used a device, or procedure within 2 months prior to the start of or during baseline
 or during the treatment period.

 5. Use of other investigational drugs within 5 half-lives of enrollment or inappropriate
 washout period in case of monoclonal antibodies, or until the expected pharmacodynamic
 effect has returned to baseline, whichever is longer.

 6. Unlikely to be able to complete all protocol required study visits or procedures,
 and/or to comply with all required study procedures.

 7. History or evidence of any other unstable or clinically significant medical condition
 that in the opinion of the investigator would pose a risk to subject safety or
 interfere with the study evaluation, procedures, or completion.

 Other protocol-defined inclusion/exclusion criteria may apply at the end.