NCT04498910已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3451838 in Adults With Treatment-Resistant Migraine
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 9
- 主要终点
- Change From Baseline in the Number of Monthly Migraine Headache Days During 1-Month
研究概览
简要总结
The reason for this study is to see if the study drug LY3451838 is safe and effective in participants who have migraine that have not responded to other preventive treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of migraine with a history of migraine headaches of at least 1 year prior, and migraine onset prior to age
- •Have completed at least 80% of required daily diary entries during the start of the study.
- •Have documentation of previous failure of 2 to 4 standard-of-care migraine preventive medication categories in the past 10 years.
- •Women of child-bearing potential must test negative for pregnancy as indicated by a negative serum pregnancy test and negative urine pregnancy test.
- •Women of child-bearing potential who are abstinent or in a same sex relationship must agree to either remain abstinent or to avoid sexual relationships with males.
- •Women of child-bearing potential who are not abstinent, must agree to use one highly effective method of contraception, or a combination of two effective methods of contraception during the study, as well as 5 months following.
- •Women not of childbearing potential may participate and include those who are: A. Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation) or congenital anomaly; or B. Post-menopausal - defined as either:
- •i. a woman at least 40 years of age with an intact uterus, not on hormone therapy, who has cessation of menses for at least 1 year without an alternative medical cause, and a follicle-stimulating hormone greater than (>) 40 multi-international units per milliliter (mIU/mL); or
- •ii. a woman 55 or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea; or
- •iii. a woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy
排除标准
- •Are currently enrolled in any other clinical study or any other type of medical research judged not to be compatible with this study.
- •Have participated, within the last 30 days or 5-half-lives (whichever is longer), in a clinical study involving any investigational product. If the half-life of the investigational product is unknown, 6 months should have passed prior.
- •Known hypersensitivity or intolerance to monoclonal antibodies or other therapeutic proteins, or to common antihistamines, epinephrine, methyl prednisone or other systemic corticosteroids.
- •Are currently receiving medication or other treatment for prevention of migraine headaches. Participants must have discontinued such medications or treatments at least 2 weeks prior. Botulinum toxin A or B that has been administered in the head or neck area use must be discontinued at least 3 months prior. Nerve blocks or device use (such as transcranial magnetic stimulation or electrical nerve stimulation) in the head or neck area for migraine treatment must be discontinued at least 30 days prior. Anti-calcitonin gene-related peptide (CGRP) antibodies must be discontinued at least 5 half-lives prior.
- •Have previously failed more than 4 migraine preventive medication categories in the past 10 years due to inadequate efficacy (that is, maximum tolerated dose for at least 2 months) and/or safety / tolerability reasons.
- •History of cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, retinal migraine, typical aura without headache, complications of migraine and migraine with brainstem aura (basilar-type migraine).
- •In the 3 months prior, have other types of headache besides migraine, tension type headache, or medication overuse headache (MOH). (In other words, participants can have migraine, tension type headache, or MOH in the 3 months prior, but they cannot have other types of headache in that time).
- •History of head or neck injury within last 6 months.
- •History of traumatic cervical or head injury associated with significant change in the quality or frequency of headaches.
- •Have reading of electrocardiogram (ECG) showing abnormalities considered incompatible with the study.
- •Any liver tests outside the normal range.
- •Evidence of significant active or unstable psychiatric disease.
- •Women who are pregnant or nursing.
- •Participants who have used opioids or barbiturate-containing analgesic >4 days per month for the treatment of pain in each of the past 3 months.
- •History of drug or alcohol abuse/dependence within 1 year.
- •Have a positive urine drug screen for illicit drugs.
- •Are unwilling or unable to comply with the use of data collection devices.
研究组 & 干预措施
1500 milligrams (mg) LY3451838
Experimental
Participants received a single intravenous (IV) dose of 1500 mg LY3451838.
干预措施: LY3451838 (Drug)
Placebo
Placebo Comparator
Participants received a single IV dose of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Number of Monthly Migraine Headache Days During 1-Month
时间窗: Baseline, Month 1
Migraine Headache Day is a calendar day on which a migraine or probable migraine headache occurs. Per International Headache Society \[IHS\] International Classification of Headache Disorders version 3 \[ICHD-3\], migraine is defined as a headache, with or without aura, of \>=30 minutes duration with both of the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Least square mean was assessed using Bayesian Mixed Model Analysis with baseline number of monthly migraine headache days as a covariate.
次要结局
- Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)(Baseline up to 5 Months)
- Change From Baseline in the Number of Monthly Headache Days During 3-Month(Baseline, Month 3)
- Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days(Month 1)
- Number of Participants With at Least One Serious Adverse Events (SAEs)(Baseline up to 5 Months)
- Pharmacokinetics (PK): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Serum Concentration (AUC 0-t) of LY3451838(Pre-infusion, end of infusion, 3hours(h), 365h, 730h, 1095h, 1460h, 1825h, 2190h, 2920h, 3650h post-infusion)
- PK: Maximum Observed Serum Concentration (Cmax) of LY3451838(Pre-infusion, end of infusion, 3hours(h), 365h, 730h, 1095h, 1460h, 1825h, 2190h, 2920h, 3650h post-infusion)
研究者
研究点 (9)
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