A 12-week phase 3, randomized, double-blind, placebo controlledstudy to evaluate the efficacy and safety of oncemonthly subcutaneous erenumab 70 mg in adult chronicmigraine patients

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Signed informed consent must be obtained prior to participation in the study.
•2. Adults Ã¢â?°Â¥ 18 to Ã¢â?°Â¤ 65 years of age upon entry into screening
•3. History of at least 5 attacks of migraine without aura and/or migraine with visual, sensory, speech and/or language, retinal or brainstem aura according to the IHS Classification ICHD-3 based on medical records and/or patient self-report.
•4. History of Ã¢â?°Â¥ 15 headache days per month of which Ã¢â?°Â¥ 8 headache days were assessed by
•the subject as migraine days per month in each of the 3 months prior to screening
•5. Ã¢â?°Â¥ 15 headache days of which Ã¢â?°Â¥ 8 headache days meet criteria as migraine days during the
•baseline period based on the eDiary calculation
•6. Demonstrated at least 80% compliance with the eDiary (e.g. must complete eDiary items
•on at least 23 out of 28 days during the baseline period) based on the eDiary calculation
•7. History of migraine (with or without aura) for Ã¢â?°Â¥ 12 months prior to screening according to
•the IHS Classification (Tassorelli et al 2018) based on medical records and/or patient selfreport

•1. Older than 50 years of age at migraine onset
•2. History of cluster headache or hemiplegic migraine headache
•3. Chronic migraine with continuous pain, in which the subject does not experience any pain
•free periods (of any duration) during the 1 month prior to screening
•4. Unable to differentiate migraine from other headaches
•5. Taken an opioid and/or opioid-containing analgesic for any indication during more than
•4 days within one month prior to the start of the baseline period or during the baseline period
•6. History of seizure disorder or other significant neurological conditions other than
•7. History of malignancy of any organ system (other than localized basal cell carcinoma of
•the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless
•of whether there is evidence of local recurrence or metastases.
•8. 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
•9. Human immunodeficiency virus (HIV) infection by history

发起方

ovartis Healthcare Pvt Ltd