Status:
WITHDRAWN
Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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,...
Eligibility Criteria
Inclusion
- key inclusion citeria
- During the Screening Epoch:
- Signed informed consent must be obtained prior to participation in the study.
- Adults ≥18 years of age upon entry into screening.
- 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).
- Patient with a documented diagnosis in clinical history of one or more of the following comorbidities: chronic fatigue, fibromyalgia and/or IBS.
- 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:
- Migraine frequency of ≥ 10 migraine days during the Baseline Epoch, confirmed by the eDiary.
- ≥ 80% eDiary compliance during the Baseline Epoch.
Exclusion
- Key Exclusion criteria
- Older than 50 years of age at migraine onset.
- Unable to differentiate migraine from other headaches.
- History of cluster headache or hemiplegic migraine headache.
- Used a device, or procedure within 2 months prior to the start of or during baseline or during the treatment period.
- 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.
- Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.
- 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.
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04114630
Start Date
October 30 2019
End Date
January 7 2022
Last Update
June 1 2020
Active Locations (27)
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1
Novartis Investigative Site
Seville, Andalicía, Spain, 41009
2
Novartis Investigative Site
Cadiz, Andalusia, Spain, 11009
3
Novartis Investigative Site
Córdoba, Andalusia, Spain, 14011
4
Novartis Investigative Site
Seville, Andalusia, Spain, 41013