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

NCT ID: NCT04114630

Last Updated: 2020-06-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2022-01-07

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.

Conditions

Migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

erenumab

Solution for s.c injection. Prefilled autoinjector

Group Type: EXPERIMENTAL

erenumab 70mg/mL

Intervention Type: DRUG

Unit dose: 70 mg/mL single-dose., prefilled erenumab autoinjectors. 140 mg dose = 2 x 70 mg/mL, single dose, prefilled erenumab autoinjectors

Interventions

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

Intervention Type: DRUG

Other Intervention Names

AMG334

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, Spain

Novartis Investigative Site

Lugo, Galicia, Spain

Novartis Investigative Site

Santiago de Compostela, Galicia, Spain

Novartis Investigative Site

Alcorcón, Madrid, Spain

Novartis Investigative Site

Fuenlabrada, Madrid, Spain

Novartis Investigative Site

Pozuelo de Alarcón, Madrid, Spain

Novartis Investigative Site

Pamplona, Navarre, Spain

Novartis Investigative Site

Elda, Valencia, Spain

Novartis Investigative Site

Valencia, Valencia, Spain

Novartis Investigational Site

Valencia, Valencia, Spain

Novartis Investigative Site

Madrid, , Spain

Novartis Investigatice Site

Madrid, , Spain

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

Madrid, , Spain

Countries

Spain

Other Identifiers

2019-001820-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAMG334AES01

Identifier Type: -

Identifier Source: org_study_id