Study of Quality of life in subjects with chronic or high-frequency episodic migraine and associated comorbidities treated with erenumab

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; 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

• Registration Number: EUCTR2019-001820-36-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified