A Randomized, Double-Blind, Cross-Over, Placebo-Controlled Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Percentage of patients who experience pain relief 2 hours following the first application of ELS-M11
研究概览
简要总结
This is a Phase 1/ Phase 2, 12-week, multi-center, randomized, double-blind, cross-over, placebo-controlled study to evaluate the efficacy and safety of ELS-M11 compared to placebo in 50 male and female subjects, aged 18 to 65 years that suffer recurring moderate-severe migraine headaches (2-8 per month).
This study is designed to describe the efficacy and safety of ELS-M11 as compared to placebo.
详细描述
Achelios is developing ELS-M11 for topical application for the acute treatment of migraine events in patients with a history of migraine with or without aura.
To be eligible for the study, patients must have a one-year documented history of migraine headache (as defined by the International Headache Society IHS), with or without aura, with 2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening visit.
The total duration of the study is the completion of five migraine headaches per subject over a maximum 12 week period followed by a 3-14 day Follow-Up Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent
- •Males and females aged 18-65 who can read, write and understand English
- •Subject has at least a one year documented history of migraine headache (defined by International headache Society IHS) migraine definitions, with or without aura, with 2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening visit
- •Is stable on the current standard non-opioid rescue medication for at least 2 months prior to randomization
- •Can distinguish migraine from tension headache (HA), with 24 hours of freedom from HA between migraine events
- •Women of childbearing potential must be currently using or willing to use contraception (30 days prior to start of study medication and for 21 days after taking study medication)
- •Women of non-childbearing potential include females regardless of age, with functioning ovaries and who have a current documented tubal ligation [Hatcher, 2004] bilateral oophorectomy or total hysterectomy, or post-menopausal females
- •The subject is able and willing to perform the assessments and procedures as specified in this protocol, including the ability to learn and follow instructions for ePRO device
排除标准
- •Migraineurs taking opioid-based rescue medications for any indication
- •Subject has history of mild migraine events or migraines that usually resolve spontaneously in less than 2 hours
- •Subject has menstrual migraines
- •Positive Drug Test
- •Subject has basilar or hemiplegic migraines
- •Subject has more than 15 headache-days per month
- •Subjects with a history of facial allodynia
- •Subject has a history of vomiting during more than 30% of migraine episodes
- •Self confinement to bed rest for more than 50% of migraine episodes
- •Subject was greater than 50 years old at age of migraine onset
- •Acute coronary syndrome (i.e., myocardial infarction and unstable angina), stroke or resuscitated cardiac arrest within the past 3 months
- •Severe congestive heart failure
- •Systolic blood pressure (sBP) >160 mmHg or diastolic blood pressure (dBP) >100 mmHg measured in the sitting position at Visit 1
- •Current active renal disease
- •Any history of pyelonephritis
- •Evidence of active liver disease
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase >2 times the upper limit of the reference range (ULRR), or total bilirubin >1.5 times the ULRR at Visit 1
- •Past history of acute pancreatitis with current triglycerides 4.56 mmol/L (400 mg/dL) at Visit 1
- •History of malignancy within the past 3 years, other than non-melanoma skin cancer (i.e., basal or superficial squamous cell carcinoma) and treated cervical cancer in-situ
- •Any planned major surgery to be performed during the study (e.g., coronary artery bypass surgery, abdominal aortic aneurysm repair, etc.)
- •Current life-threatening condition
- •Significant hypersensitivity to NSAIDs (e.g., difficulty swallowing or breathing, tachycardia, anaphylaxis, angioedema or skin reaction)
- •Pregnancy (defined by positive urine pregnancy test) or lactation at Visit 1, or planning to become pregnant prior to completion of the study
- •History or suspicion of alcohol or substance abuse (current or past 6 months).
- •Participation in any clinical trial within 30 days prior to Visit 1
- •Subjects with a history of hypersensitivity to products containing tiaprofenic acid, suprofen, fenofibrate, oxybenzone, or octocrylene (e.g., sunscreen, perfume)
- •Subjects with a history of photosensitivity
- •Any clinically significant abnormality or any reason that the subject may not be able to complete the full study observational period
研究组 & 干预措施
ELS-M11
Topical 5% ELS-M11 (3 g)
干预措施: ELS-M11 (Drug)
ELS-M11
Topical 5% ELS-M11 (3 g)
干预措施: Placebo (Drug)
Placebo
A matching formulation with no active ingredient
干预措施: ELS-M11 (Drug)
Placebo
A matching formulation with no active ingredient
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of patients who experience pain relief 2 hours following the first application of ELS-M11
时间窗: 2 hours
Pain relief (as defined by a one point decrease on a 4 point pain intensity scale) in subjects experiencing a moderate to severe migraine headache, 2 hours after the initial application of ELS-M11.
次要结局
- Percentage of patients who can resume or maintain their normal routine, following the first application of ELS-M11.(24 hours)
- Percentage of patients who report sustained pain relief after the first application of ELS-M11(24 hours)
- Time to Initial Use of Rescue Medication following the first application of ELS-M11(24 hours)
- Percentage of patients who report pain relief at various time points within a 24 hour period, following the first application of ELS-M11(24 hours)
- Percentage of patients who report sustained complete pain resolution after the first application of ELS-M11.(24 hours)
- Use of Rescue Medication following the first application of ELS-M11 by 24 hours(24 hours)
- Percentage of patients who report complete pain resolution within 24 hours following the first application of ELS-M11.(24 hours)
- Resolution of migraine-associated symptoms, following the first application of ELS-M11(24 hours)