Clinical trial NCT04114630: Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Migraine
Keywords: Chronic migraine
Migraine
Transformative migraine
Neurologic disease
Unremitting pain
Progressive over time
Nausea
Vomiting
Sensitivity to light,
Sensitivity to sound
Pain localized to one side of head,
Painful headache
Pain in head
Head throbbing
Sinus headache
Pounding headache
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2019-10-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Baseline up to approximately 12 months
Secondary outcomes:
measure: Association between MSQ 2.1 and other HRQoL scores in each comorbidity (fibromyalgia, chronic fatigue, and/or IBS).
timeFrame: Baseline, month 3, 6 and 12.
measure: Mean change in HRQoL
timeFrame: Baseline, month 6 and 12.
measure: Patient profile: number of migraine episodes/month
timeFrame: Baseline
measure: Duration and exposure of 70 and 140 mg doses of erenumab
timeFrame: Baseline up to approximately 1 year
measure: Change in the mean number of migrane days per month from baseline to month 12
timeFrame: From baseline to month 12
measure: Change in the mean number of days of use of acute migraine-specific medication per month from baseline to month 12
timeFrame: From baseline to month 12.
measure: 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.
timeFrame: From baseline to month 12
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalicía
city: Cadiz
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Córdoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucía
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
state: Aragón
city: Valladolid
country: Spain
facility: Novartis Investigative Site
state: Castilla León
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: L'Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Elda
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigational Site
state: Comunidad Valenciana
city: Lugo
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Palma de Mallorca
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
city: Santa Cruz de Tenerife
country: Spain
facility: Novartis Investigative Site
state: Islas Canarias
city: Alcorcón
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Fuenlabrada
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Pozuelo de Alarcón
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Pamplona
country: Spain
facility: Novartis Investigative Site
state: Navarra
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
state: País Vasco
city: Bilbao
country: Spain
facility: Novartis Investigative Site
state: País Vasco
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigatice Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: