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

Migraine Clinical Trial

— COMIG  

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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04114630
• Other study ID #: CAMG334AES01
• Secondary ID: 2019-001820-36
• Status: Withdrawn
• Phase: Phase 3
• Start date: October 30, 2019
• Est. completion date: January 7, 2022

Study information

• Verified date: September 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 7, 2022
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
Spain	Novartis Investigative Site	Alcorcón	Madrid
Spain	Novartis Investigative Site	Baracaldo	País Vasco
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Bilbao	País Vasco
Spain	Novartis Investigative Site	Cadiz	Andalucia
Spain	Novartis Investigative Site	Córdoba	Andalucia
Spain	Novartis Investigative Site	Elda	Comunidad Valenciana
Spain	Novartis Investigative Site	Fuenlabrada	Madrid
Spain	Novartis Investigative Site	L'Hospitalet de Llobregat	Cataluña
Spain	Novartis Investigative Site	Lugo	Galicia
Spain	Novartis Investigatice Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Palma de Mallorca	Islas Baleares
Spain	Novartis Investigative Site	Pamplona	Navarra
Spain	Novartis Investigative Site	Pozuelo de Alarcón	Madrid
Spain	Novartis Investigative Site	Santa Cruz de Tenerife	Islas Canarias
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Spain	Novartis Investigative Site	Sevilla	Andalicía
Spain	Novartis Investigative Site	Sevilla	Andalucía
Spain	Novartis Investigational Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valladolid	Castilla León
Spain	Novartis Investigative Site	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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