EUCTR2019-001989-15-DE进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Followed by an Open-Label Extension to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients with Major Depressive Disorder - UNITE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a. The patient is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in this protocol.
- •b. The patient is male or female and 18 to 70 years of age, inclusive.
- •c. The patient has a diagnosis of migraine with onset at =50 years of age.
- •d. Prior to the screening visit (V1), the patient has a 12-month history of either:
- •??-migraine (according to ICHD-3 criteria) or
- •??-headache consistent with migraine (ie, migraine diagnosis not better accounted for by another ICHD-3 diagnosis)
- •e. The patient fulfills the following criteria for migraine in a prospectively collected diary during the 28-day baseline period:
- •??-on =4 days, headache attacks qualified as migraine based on the following ICHD-3 criteria:
- •-ICHD-3 diagnostic criteria C and D for 1.1 Migraine without aura
- •-headache has at least 2 of the following 4 characteristics: unilateral location; pulsating quality; moderate or severe pain intensity;
- •and aggravation by, or causing avoidance of, routine physical activity (eg, walking or climbing stairs)
- •-during headache, at least one of the following: nausea and/or vomiting; photophobia and phonophobia
- •-ICHD-3 criteria B and C for 1.2 Migraine with aura
- •-1 or more of the following fully reversible aura symptoms: visual, sensory, speech and/or language, motor, brainstem, retinal
- •-at least 2 of the following 4 characteristics: at least 1 aura symptom spreads gradually over =5 minutes, and/or 2 or more symptoms
- •occur in succession; each individual aura symptom lasts 5 to 60 minutes; at least 1 aura symptom is unilateral; the aura is
- •accompanied, or followed within 60 minutes, by headache not better accounted for by another ICHD-3 diagnosis, and transient
- •ischemic attack has been excluded
- •-probable migraine (a migraine subtype where only 1 migraine criterion is missing)
- •-triptan or ergot derivative used to treat an established headache.
- •f. The patient agrees not to initiate any migraine preventive medications during the study. Up to 30% of patients, however, may take a single such medication previously prescribed for the treatment of migraine.
- •g. The patient has a history of MDD according to the DSM-V criteria at least 12 months prior to the screening visit (V1). Patients may take a single medication prescribed for the treatment of depression as long as the dose of that medication has been stable for at least 8 weeks prior to the screening visit (V1) and expects to remain at the stable dose throughout the study.
- •h. The patient has a PHQ-9 score of at least 10 at the screening visit (V1).
- •i. The patient has a Mini Mental State Examination score of at least 26 points at the screening visit (V1).
- •j. The patient is in good health in the opinion of the investigator as determined by medical evaluation, including medical and psychiatric history, physical examination, laboratory tests, and cardiac monitoring.
- •k. The patient has a body weight >-45 kg and a body mass index within the range of 17.5 to 34.9 kg/m2, inclusive.
- •l. The patient demonstrated compliance with the electronic headache diary during the 28-day baseline period by entry of headache data on a minimum of 21 days cumulative during the 28-day baseline period (~75% diary compliance).
- •m. Women may be included only if they have a negative serum beta-hu
排除标准
- •a. The patient uses medications containing opioids (incl. codeine) or barbiturates (incl. butalbital/aspirin/caffeine, butalbital/paracetamol/caffeine, or any other combination containing butalbital) on more than 4 days during the 28-day baseline period for the treatment of migraine or for any other reason.
- •b. The patient has failed 4 or more different medication classes to treat depression.
- •c. If in the clinical judgment of the investigator/qualified psychiatrist, the patient's antidepressant medication needs to be changed or doseadjusted during the 28-day baseline period.
- •d. The patient has used an intervention/device for migraine/depression 2 months prior screening.
- •e. The patient has used electroconvulsive therapy at any time.
- •f. The patient suffers from constant/nearly constant headache, defined as having headaches for more than 80% of the time he/she is awake, and less than 4 days without headache per month. Daily headache is acceptable if patient has headaches 80% or less of the time he/she is awake on most days.
- •g. The patient has clinically significant disease (e.g. hematological, cardiac, renal, endocrine, pulmonary etc.), at the discretion of the investigator.
- •h. The patient has a clinical history of a severe/uncontrolled psychiatric disorder or any clinically significant psychiatric history that would likely interfere with full participation in the study such as suicide attempt (lifetime exclusion) and suicidal ideation/other psychoactive spectrum disorders incl. schizoaffective/delusional disorder, depression with psychotic features/catatonic disorder (in the past 6 months exclusion)
- •i. The patient has a history of clinically significant cardiovascular disease/vascular ischemia or thromboembolic events (arterial/venous thrombotic/embolic events), e.g. cerebrovascular accident (incl. transient ischemic attacks), deep vein thrombosis, or pulmonary embolism.
- •j. The patient has a known infection/history of HIV, tuberculosis, any history of Lyme disease, or chronic hepatitis B/C infection.
- •k. The patient has a past/current history of cancer, except for appropriately treated non-melanoma skin carcinoma.
- •l. The patient is a pregnant/nursing female or plans to become pregnant during the study, incl. the 6-month period after the administration of the last dose.
- •m. The patient has a history of hypersensitivity reactions to injected proteins, incl. monoclonal antibodies/Stevens-Johnson Syndrome/toxic epidermal necrolysis syndrome.
- •n. The patient has participated in a clinical study of a new chemical entity or a prescription medicine within 2 months of the screening visit (V1) or 3 months in case of biologics if the half-life of the biologics is unknown or 5 half-lives, whichever is longer, or is currently participating in another study of an IMP (or a medical device).
- •o. The patient has failed treatment with any monoclonal antibodies targeting the CGRP pathway or have taken the medications within 5 halflives of the screening visit or take them during the study.
- •p. The patient has any finding in the baseline 12-lead electrocardiogram considered clinically significant in the judgment of the investigator.
- •q. The patient has any finding that, in the judgment of the investigator,is a clinically significant abnormality, incl. serum chemistry, hematology, coagulation, and urinalysis test values.
- •r. The patient has hepatic enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) >1.5 × the upper limit of the norm
研究者
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