CTRI/2019/05/019167已完成3 期
Protocol H8H-MC-LAIJ(a)Randomized Controlled Trial of Lasmiditan Over FourMigraine Attacks
Eli Lilly and Company India Pvt Ltd0 个研究点目标入组 66 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
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
入选标准
- •[1] are of an acceptable age to provide informed consent according to the local regulations
- •and are at least 18 years of age at time of screening (Visit 1) with migraine with or
- •without aura fulfilling the IHS diagnostic criteria 1.1 or 1.2.1
- •[2] history of disabling migraine for at least 1 year
- •[3] migraine onset before the age of 50 years
- •[4] history of 3 to 8 migraine attacks per month ( <15 headache days per month) during the
- •past 3 months
- •[5] MIDAS score ââ?°Â¥11
- •[6] able and willing to complete an eDiary to record the details of each migraine attack
- •treated with study drug
- •[7] are men or women; if women, must agree to abide by the following guidance:
- •women of child-bearing potential must agree to use a highly effective method of
- •contraception (that is, one with less than 1% failure rate) such as combination oral
- •contraceptives, implanted/injected contraceptives, intrauterine devices, or sterile partner
- •until 30 days after the last dose of study medication
排除标准
- •[1] known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
- •[2] history or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the
- •patient at increased risk of seizures
- •[3] history of recurrent dizziness and/or vertigo including benign paroxysmal positional
- •vertigo, Meniereââ?¬•s disease, vestibular migraine, and other vestibular disorders
- •[4] history of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy)
- •[5] history of orthostatic hypotension with syncope
- •[6] significant renal or hepatic impairment in the opinion of the investigator or if they meet
- •hepatic monitoring criteria
- •[7] history, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is ââ?°Â¥15 headache days per month
- •[8] use of more than 3 doses per month of either opioids or barbiturates
- •[9] initiation of or a change in concomitant medication to reduce the frequency of migraine
- •episodes within 3 months prior to Screening/Visit 1
- •[10] female patients who are pregnant or breast-feeding
- •[11] women of child-bearing potential who test positive for pregnancy based on a serum pregnancy test collected at Visit 1
- •[12] history of drug or alcohol abuse/dependence within 1 year prior to Visit 1(excessive or compulsive use as judged by the investigator), or currently using drugs of potential abuse or any prescribed or over-the-counter medication in a
- •manner that the investigator considers indicative of abuse/dependence
- •[13] have a positive urine drug screen for any substances of abuse at Visit 1
- •[14] have an acute, serious or unstable medical condition, or a history or presence of any other medical illness including but not limited to any autoimmune disease,CV, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease, or any clinically significant laboratory abnormality, that, in the judgment of the investigator, indicates a medical problem that would preclude study
- •participation
- •[15] known hypersensitivity to multiple drugs
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