A proof of concept study of the efficacy and safety of oral LAT8881 in acute migraine

ateral Pharma Pty Ltd0 个研究点目标入组 21 人开始时间: 2019年10月8日最近更新: 2021年5月10日

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 21

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 18 Years 至 75 Years（—）
性别: All

入选标准

•Subjects must meet the following criteria to be entered into the study:
•1.Males or females aged 18 to 75 years at the time of consent
•2.Diagnosis of episodic migraine headache at least 12 months ago with or without aura as defined in ICHD-3-beta2
•3.Onset of migraine headache before age 50
•4.Medical history of 2 – 8 migraine headache attacks per month for the previous 12 months; with at least 75% of attacks progress to moderate or severe pain within 2 hours (ie, rapidly-escalating)
•5.Minimum 48 hours on average between migraine headache attacks
•6.Acute headache medication on less than 14 days/month in the 3 months prior to screening
•7.Willing and able to comply with all study procedures including completion of a headache diary and a migraine diary on the day of a migraine headache
•8. Female subjects must be:
•a)of non-child-bearing potential [surgically sterilised or postmenopausal (12 months with no menses without alternative medical cause)] OR
•b)not pregnant, breast feeding or planning to become pregnant AND willing to comply with the medically acceptable contraceptive requirements of the study from screening to at least 28 days after the last IMP administration.
•9. Male subjects with female partners of childbearing potential must useadequate and highly effective methods of contraception, from screening until 28 days after their last IMP administration.
•10. Subjects must be sufficiently competent in English to understand the purposes
•and risks of the study and to provide written informed consent

排除标准

•Subjects who meet any of the following criteria will be excluded from the study:
•1.Unable to distinguish migraine from other primary headache conditions
•2.Average of 15 or more headache (migraine or nonmigraine) days per month or history of more than 25% of headaches occurring at time of wakening (wake up headaches)
•3.History of aura lasting more than 60 minutes
•4.History of vomiting within 2 hours of onset of a migraine headache in more than 25% of migraine headaches
•5.Medication overuse headache, defined as:
•a.use of opioids, triptans or ergot alkaloids or any combination of these medications for treatment of headaches 10 or more days per month during the 90 days prior to screening OR
•b.Non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics for treatment of headaches on more than 14 days per month during the 90 days prior to screening
•6.Recent (3 years) history of frequent or chronic hemiplegic/ basilar migraine, tension headache, retinal migraine, ophthalmoplegic migraine as per ICHD classification, or treatment resistant atypical migraine
•7.Hospital admission for status migrainosis or medication overuse headache within 6 months of screening
•8.Current clinically significant systemic disease or neurological or psychiatric condition which in the opinion of the investigator or sponsor could jeopardise the safety of the subject or the validity of the study results
•9.Cerebrovascular disease, including but not limited to a history of stroke or recent (3 years) transient ischaemic attack (TIA)
•10.Major surgery within 6 weeks of screening or planned during the study period
•11.Clinically significant abnormality as assessed by the investigator or sponsor’s medical monitor on haematology, biochemistry, vital signs, physical examination or 12-lead electrocardiogram (ECG)
•12.Malignancy within 5 years of screening, with the exception of carcinoma in situ, non-melanoma skin cancers and prostate cancer not requiring treatment or on stable (> 6 months) treatment with hormone therapy
•13.History of alcohol abuse, illicit or illegal drug use in the last 2 years
•14.Use of prohibited medications or treatments within the specified time period before Screening or planned during the study
•15.Participation in another clinical trial or administration of any investigational product or experimental product within 60 days or 5 half-lives (whichever is longer) prior to screening
•16.History of significant hypersensitivity to LAT8881 (formerly known as AOD9604), excipients in the drug product formulation or drugs of a similar chemical or pharmacological class.
•17.Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
•18.An employee of the sponsor or research site personnel directly affiliated with this study, whether biological or legally adopted, or their immediate family members, defined as a spouse, parent, sibling, or child

研究者

发起方

ateral Pharma Pty Ltd

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