EUCTR2015-004550-18-FI进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Long Term Safety, Tolerability, and Efficacy of Subcutaneous Administration of TEV 48125 for the Preventive Treatment of Migraine
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,890
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
入选标准
- •Patients Rolling Over from the Pivotal Efficacy Studies: Patients may be included in this study only if they meet all of the following criteria:
- •a. Patient signs and dates the informed consent document.
- •b. Patient must have completed the pivotal efficacy study without major protocol violations.
- •c. Patients may continue with a stable dose/regimen of the preventive medication they were taking during the pivotal efficacy studies.
- •d. Patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol.
- •Patients Not Rolling Over from the Pivotal Efficacy Studies: Patients may be included in this study only if they meet all of the following criteria:
- •a. Males or females aged 18 to 70 years, inclusive, with migraine onset at =50 years of age.
- •b. Patient signs and dates the informed consent document.
- •c. Patient has history of migraine (according to ICHD-3 criteria [Classification Committee of the IHS, 2013]) or clinical judgment suggests a migraine diagnosis (not better accounted for by another ICHD-3 diagnosis) for =12 months prior to screening.
- •d. Patient fulfills the following criteria for EM or CM with prospectively collected baseline information during the 28-day run-in period:
- •-Patients with EM:
- •? headache occurring on =4 and =14 days
- •? on =4 days, fulfilling any of the following:
- •? ICHD-3 diagnostic criteria C and D for 1.1 Migraine without aura
- •? ICHD-3 criteria B and C for 1.2 Migraine with aura
- •? Probable migraine (a migraine subtype where only 1 migraine criterion is missing)
- •? The patient used a triptan or ergot derivative to treat an established headache.
- •- Patients with CM:
- •? headache occurring on =15 days
- •? on =8 days, fulfilling any of the following:
- •? ICHD-3 diagnostic criteria C and D for 1.1 Migraine without aura
- •? ICHD-3 criteria B and C for 1.2 Migraine with aura
- •? Probable migraine (a migraine subtype where only 1 migraine criterion is missing)
- •? The patient used a triptan or ergot derivative to treat an established headache.
- •e. Not using preventive medications (ie, at least 5 half-lives have passed since last use) or using no more than 1 preventive medication for migraine or other medical conditions (eg, propranolol used for hypertension) if the dose and regimen have been stable for at least 2 months prior to beginning the 28-day run-in period.
- •f. Body mass index of 17.5 to 37.5 kg/m2 and a total body weight between 45 and 120 kg, inclusive
- •g. All patients must be of nonchildbearing potential, defined as:
- •- women surgically sterile by documented complete hysterectomy, bilateral oophorectomy, or bitubal ligations or confirmed to be postmenopausal (at least 1 year since last menses and follicle-stimulating hormone above 35 U/L)
- •- men surgically sterile by documented vasectomy
- •if of childbearing potential, patients must meet an
排除标准
- •Patients Rolling Over from the Pivotal Efficacy Studies: Patients will be excluded from participating in this study if they meet any of the following criteria:
- •a. Any finding that, in the judgment of the investigator, is clinically significantly abnormal, including hematology values, serum chemistry, coagulation tests, or urinalysis (abnormal tests may be repeated for confirmation)
- •b. Pregnant or nursing females
- •c. Any finding in the baseline 12-lead ECG considered clinically significant in the judgment of the investigator
- •d. Compliance with daily diary entry lower than 75% at the last month of the double-blind treatment period of the pivotal efficacy study
- •Patients Not Rolling Over from the Pivotal Efficacy Studies: Patients will be excluded from participating in this study if they meet any of the following criteria:
- •a. Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator
- •b. Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years
- •c. History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events) such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism
- •d. Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection
- •e. Past or current history of cancer in the past 5 years, except for appropriately treated nonmelanoma skin carcinoma
- •f. Pregnant or nursing females
- •g. History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
- •h. Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study drug administration or 5 half-lives, whichever is longer
- •I. Any finding in the baseline 12 lead ECG considered clinically significant in the judgment of the investigator
- •j. Any finding that, in the judgment of the investigator, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation)
- •k. Hepatic enzymes (alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase) >1.5 × the upper limit of the normal range (ULN) after confirmation in a repeat test or suspected hepatocellular damage that fulfills criteria for Hy’s law at screening
- •l. Serum creatinine >1.5 × the ULN, clinically significant proteinuria, or evidence of renal disease at screening
- •m. History of alcohol or drug abuse during the past 2 years, or alcohol or drug dependence during the past 5 years
- •n. The patient cannot participate or successfully complete the study, in the opinion of their healthcare provider or the investigator, for any of the following reasons:
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