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 - COMIG

ovartis Farmacéutica, S.A.0 个研究点目标入组 300 人开始时间: 2019年7月4日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•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

•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.

发起方

ovartis Farmacéutica, S.A.