NL-OMON47278撤回3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled,<br>Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens<br>(Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 versus Placebo for the<br>Prevention of Episodic Cluster Headache - TV48125-CNS-30056
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- TEVA Pharma
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •a. Patients are capable of giving signed informed consent as described in Appendix D
- •which includes compliance with the requirements and restrictions listed in the
- •informed consent form (ICF) and in this protocol.
- •b. The patient is a man or woman 18 to 70 years of age, inclusive.
- •c. The patient has a history of ECH according to ICHD-3 beta criteria (Headache
- •Classification Committee of the IHS 2013) for *12 months prior to screening
- •including the following:
- •* Attacks of severe, strictly unilateral pain which is orbital, supraorbital, temporal
- •or in any combination of these sites, lasting 15 to 180 minutes and occurring from
- •once daily every other day to 8 times a day for more than half of the time when
- •the disorder is active
- •* The pain is associated with at least 1 of the following symptoms or signs:
- •ipsilateral conjunctival injection, lacrimation, nasal congestion, rhinorrhea,
- •forehead and facial sweating, miosis and/or ptosis and/or eyelid edema, and/or
- •sense of restlessness or agitation.
- •CH attacks occurring in periods lasting from 7 days to 1 year, separated by
- •pain-free periods lasting at least 1 month.
- •d. CH attacks of a new cluster cycle have started within 2 weeks (14 days, inclusive) prior to
- •screening and, based on the patient*s previous medical history, it is expected that
- •the patient*s CH attacks will continue for *6 weeks after the screening visit.
- •e. The patient has a total body weight of *45 kg
- •f. The patient is not using or using * 2 concomitant medications that are
- •commonly prescribed as preventive treatments for CH (Appendix H), regardless of
- •the indication for which the medication was prescribed. Patients must be on a stable
- •dose and regimen for at least 2 weeks prior to screening and throughout the study.
- •g. If a patient is receiving Botox, it should be in a stable dose regimen, considered as having *2 cycles of Botox prior to screening. The patient should not receive Botox during the run-in period up to the evaluation period (4 weeks) where the primary endpoint is evaluated.
- •h. The patient has demonstrated compliance with the electronic headache diary during
- •the run-in period by entry of headache data on 85% of days during the run-in period.
- •i. The patient has at least 7 CH attacks during the run-in period.
- •j. The patient is in good health in the opinion of the investigator as determined by a
- •medical and psychiatric history; medical examination; 12-lead ECG; and serum
- •chemistry, hematology, coagulation, and urinalysis.
- •k. Women may be included only if they have a negative serum beta-human chorionic
- •gonadotropin (*-HCG) test at screening, are sterile or postmenopausal, and are not lactating. Definitions of
- •sterile and postmenopausal are given in Appendix E.
- •l. Women of childbearing potential (WOCBP) whose male partners are potentially
- •fertile (ie, no vasectomy) must use highly effective birth control methods for the
- •duration of the study (ie, starting at screening) and for 7.5 months after
- •discontinuation of IMP.
- •m. Men must be sterile, or if they are potentially fertile/reproductively competent (not
- •surgically [eg, vasectomy] or congenitally sterile) and their female partners are of
- •childbearing potential, must agree to use, together with their female partners, acceptable birth
- •control methods for the duration of the study and for 7.5 months after
排除标准
- •a. The patient has used systemic steroids for any reason (including treatment of the current CH cycle) within *7 days prior to screening.
- •b. The patient reports using butalbital on more than 7 days during the 4 weeks prior to
- •screening or using butalbital on more than 3 days during the screening/run-in period.
- •c. The patient reports using opioids on more than 15 days during the 4 weeks prior to
- •screening or using opioids on more than 4 days during the screening/run-in period.
- •d. The patient has used an intervention/device (eg, scheduled nerve blocks) for headache
- •during the 4 weeks prior to screening.
- •e. The patient has clinically significant hematological, renal, endocrine, immunologic, pulmonary,
- •gastrointestinal, genitourinary, cardiovascular, neurologic, hepatic, or ocular disease at the
- •discretion of the investigator.
- •f. The patient has evidence or medical history of clinically significant psychiatric issues
- •determined at the discretion of the investigator.
- •g. The patient has a history of any suicide attempt in the past or current active suicidal
- •ideation, as measured by the eC-SSRS.
- •h. The patient has a 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.
- •i. The patient has a past or current history of cancer or malignant tumor in the past 5 years, except for appropriately treated non-melanoma skin carcinoma.
- •j. The patient is pregnant or lactating.
- •k. The patient has a history of hypersensitivity reactions to injected proteins, including
- •monoclonal antibodies.
- •l. The patient has participated in a clinical study of a new chemical entity or a
- •prescription medicine within 2 months or 5 half-lives before administration of the
- •first dose of the IMP, whichever is longer.
- •m. The patient has participated in a clinical study of a monoclonal antibody within 3 months or 5 half-lives before administration of the first dose of the IMP, whichever is longer, unless it is
- •known that the patient received placebo during the study.
- •n. The patient has a history of prior exposure to a monoclonal antibody targeting the
- •CGRP pathway (AMG 334, ALD304, LY2951742, or fremanezumab). If patient has participated in a clinical study with any of these monoclonal antibodies, it has to be confirmed that the patient received placebo in order to be eligible for this study).
- •o. The patient has any finding in the baseline 12-lead ECG considered clinically
- •significant in the judgment of the investigator.
- •p. The patient has 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).
- •q. The patient has hepatic enzymes (alanine aminotransferase [ALT] and aspartate
- •aminotransferase [AST]) >1.5 × the upper limit of normal (ULN) range after
- •confirmation in a repeat test, or the patient has suspected hepatocellular damage that
- •fulfills criteria for Hy*s law at screening.
- •r. The patient has serum creatinine >1.5 × the ULN or evi
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