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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Unit dose: 70 mg/mL single-dose., prefilled erenumab autoinjectors. 140 mg dose = 2 x 70 mg/mL, single dose, prefilled erenumab autoinjectors
Novartis Investigative Site
Seville, Andalicía, Spain
Novartis Investigative Site
Cadiz, Andalusia, Spain
Novartis Investigative Site
Córdoba, Andalusia, Spain
Novartis Investigative Site
Seville, Andalusia, Spain
Novartis Investigative Site
Zaragoza, Aragon, Spain
Novartis Investigative Site
Palma de Mallorca, Balearic Islands, Spain
Novartis Investigative Site
Barakaldo, Basque Country, Spain
Novartis Investigative Site
Bilbao, Basque Country, Spain
Novartis Investigative Site
Santa Cruz de Tenerife, Canary Islands, Spain
Novartis Investigative Site
Valladolid, Castille and León, Spain
...and 17 more locations
Percentage of patients (in the overall population and by each comorbidity) who achieve a ≥5-point increase in the MSQ-RFR, MSQ-RFP domains and a ≥8-point increase in the MSQ-EF domain of the Migraine-Specific Quality of Life Questionnaire (MSQ 2.1)
MSQ 2.1 consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);\&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), \& are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement. Comorbidities include fibromyalgia, chronic fatigue, and/or irritable bowel syndrome (IBS)
Time frame: Baseline up to approximately 12 months
Association between MSQ 2.1 and other HRQoL scores in each comorbidity (fibromyalgia, chronic fatigue, and/or IBS).
Correlation between HRQoL scores in migraine questionnaire (MSQ 2.1) and HRQoL scores in each comorbidity questionnaire: fibromyalgia (Fibromyalgia Impact Questionnaire, FIQ), chronic fatigue (Short Form health survey, SF-12) and IBS (Irritable Bowel Syndrome Quality of Life, IBS-QOL) in all study visits.
Time frame: Baseline, month 3, 6 and 12.
Mean change in HRQoL
Health Related Quality of Life (HRQoL) in patients with migraine and at least once of these comorbitiy (fibromyalgia, chronic fatigue and irritable bowel syndrome \[IBS\])
Time frame: Baseline, month 6 and 12.
Patient profile: number of migraine episodes/month
This description can help to understand the baseline characteristics of patients treated with erenumab and the relation with the outcomes
Time frame: Baseline
Duration and exposure of 70 and 140 mg doses of erenumab
Dosing information will be collected throughout the trial including dose modifications and missed doses to provide total exposure of drug over time.
Time frame: Baseline up to approximately 1 year
Change in the mean number of migrane days per month from baseline to month 12
• Efficacy of erenumab will be assessed by migraine days.
Time frame: From baseline to month 12
Change in the mean number of days of use of acute migraine-specific medication per month from baseline to month 12
• Efficacy of erenumab.
Time frame: From baseline to month 12.
Percentage of patients who achieve at least 50% or greater reduction in the mean number of migraine days per month from baseline to month 12.
• Efficacy of erenumab.
Time frame: From baseline to month 12
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