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

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

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 Overview

• Status: Withdrawn
• Conditions: Migraine
• Intervention / Treatment: Drug: erenumab 70mg/mL

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Novartis Investigative Site
  • Madrid, Spain, 28040
    • Novartis Investigative Site
  • Madrid, Spain, 28003
    • Novartis Investigative Site
  • Madrid, Spain, 28006
    • Novartis Investigatice Site
  • Andalicía
    • Sevilla, Andalicía, Spain, 41009
      • Novartis Investigative Site
  • Andalucia
    • Cadiz, Andalucia, Spain, 11009
      • Novartis Investigative Site
    • Córdoba, Andalucia, Spain, 14011
      • Novartis Investigative Site
  • Andalucía
    • Sevilla, Andalucía, Spain, 41013
      • Novartis Investigative Site
  • Aragón
    • Zaragoza, Aragón, Spain, 50009
      • Novartis Investigative Site
  • Castilla León
    • Valladolid, Castilla León, Spain, 47005
      • Novartis Investigative Site
  • Cataluña
    • Barcelona, Cataluña, Spain, 08035
      • Novartis Investigative Site
    • Barcelona, Cataluña, Spain, 08003
      • Novartis Investigative Site
    • Barcelona, Cataluña, Spain, 08041
      • Novartis Investigative Site
    • L'Hospitalet de Llobregat, Cataluña, Spain, 08907
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Elda, Comunidad Valenciana, Spain, 03600
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46026
      • Novartis Investigational site
  • Galicia
    • Lugo, Galicia, Spain, 27003
      • Novartis Investigative Site
    • Santiago de Compostela, Galicia, Spain, 15706
      • Novartis Investigative Site
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07120
      • Novartis Investigative Site
  • Islas Canarias
    • Santa Cruz de Tenerife, Islas Canarias, Spain, 38010
      • Novartis Investigative Site
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Novartis Investigative Site
    • Fuenlabrada, Madrid, Spain, 28942
      • Novartis Investigative Site
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Novartis Investigative Site
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Novartis Investigative Site
  • País Vasco
    • Baracaldo, País Vasco, Spain, 48903
      • Novartis Investigative Site
    • Bilbao, País Vasco, Spain, 48013
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: erenumab; Solution for s.c injection. Prefilled autoinjector	Drug: erenumab 70mg/mL; Unit dose: 70 mg/mL single-dose., prefilled erenumab autoinjectors. 140 mg dose = 2 x 70 mg/mL, single dose, prefilled erenumab autoinjectors; Other Names: AMG334

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline up to approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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])	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	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.	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.	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.	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.	From baseline to month 12

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2019
• Primary Completion (Anticipated): December 6, 2021
• Study Completion (Anticipated): January 7, 2022

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Nausea; Vomiting; Migraine; Chronic migraine; Transformative migraine; Neurologic disease; Unremitting pain; Progressive over time; Sensitivity to light,; Sensitivity to sound; Pain localized to one side of head,; Painful headache; Pain in head; Head throbbing; Sinus headache; Pounding headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Calcitonin Gene-Related Peptide Receptor Antagonists; Erenumab
• Other Study ID Numbers: CAMG334AES01; 2019-001820-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes