Study of Quality of life in subjects with chronic or high-frequency episodic migraine and associated comorbidities treated with erenumab MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: AIMOVIG
Product Name: erenumab
Product Code: AMG334
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Pro
Sponsors
Novartis Farmacéutica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess HRQoL, measured by the Migraine-Specific Quality of Life Questionnaire (MSQ 2.1), after treatment with erenumab in patients with CM or HFEM who present at least one associated comorbidity (fibromyalgia, chronic fatigue, and/or IBS).; Secondary Objective: Objective 1: To assess the association between MSQ 2.1 and other HRQoL scores in each comorbidity (fibromyalgia, chronic fatigue, and/or IBS). Objective 2: To assess change in HRQoL in each comorbidity (fibromyalgia, chronic fatigue, and IBS). Objective 3: To assess the efficacy of erenumab. Objective 4: To describe the profile of patients treated with erenumab Objective 5: To collect and evaluate safety data in patients with CM or HFEM treated with erenumab. Objective 6: To describe the management of erenumab (70-140 mg) in patients with CM or HFEM. ;Primary end point(s): • 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 MSQ 2.1 from baseline to 6 and 12 months;Timepoint(s) of evaluation of this end point: From baseline to 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: From baseline to 6 and 12 months; Secondary end point(s): •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. • Mean change in HRQoL in each associated comorbidity from baseline to 6 and 12 months assessed with the FIQ, SF-12 and IBS-QOL in patients with fibromyalgia, chronic fatigue and IBS, respectively. • Efficacy of erenumab will be assessed by migraine days.-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. - Change in the mean number of migraine days per month 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. • Exploratory: -Correlation between the monthly mean number of days with migraine and scores obtained in the Modified Migraine Disability Assessment scale (mMIDAS). - Correlation between mean number of days with migraine and the scores obtained in the 6-item WPAI-G (Work Productivity and Activity Impairment General) questionnaire. -Comparison of mean change in MSQ 2.1 (MSQ-RFR, MSQ-RFP and MSQ-EF) scores from baseline to 6 and 12 months between patients with one comorbidity and patients with two or more comorbidities (in the overall population and by each comorbidity) | — |
Countries
Spain
Contacts
Public ContactTrial Monitoring Organization (TMO)
Novartis Farmacéutica, S.A.
Outcome results
None listed