A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
研究概览
简要总结
This is a randomised, placebo controlled, double blind, crossover proof of concept study to investigate the efficacy and safety of oral LAT8881 in acute migraine, with or without aura.
详细描述
Subjects enrolled in the study will be randomised to receive investigational medicinal product (LAT8881 60 mg or placebo), to be taken at the onset (within one hour from the onset of pain) of a migraine headache of moderate to severe intensity [Numeric rating scale greater than 4]. Rescue medication should not be taken until at least 2 hours post dose. Subjects will be given a single dose of either active or placebo, to treat one migraine headache.
After treatment of one migraine headache (or a maximum 28 days) the subject will return to the clinic for re-evaluation and crossover to the second treatment. After treatment of one migraine headache in the second treatment period or a maximum of 28 days from commencement of the second treatment period, the subject will return to the clinic for re-evaluation. An End of study visit (telephone) will occur 7 days after the end of the second treatment 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 to 75 years at the time of consent
- •Diagnosis of episodic migraine headache at least 12 months ago with or without aura as defined in International Classification of Headache-3
- •Onset of migraine headache before age 50
- •Medical history of 2 - 8 migraine headache attacks per month for the previous 12 months; ≥ 75% of attacks progress to moderate or severe pain within 2 hours (ie, rapidly-escalating)
- •Minimum 48 hours on average between migraine headache attacks
- •Acute headache medication on ≤ 14 days/month in the 3 months prior to screening
- •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
排除标准
- •Unable to distinguish migraine from other primary headache conditions
- •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)
- •History of aura lasting more than 60 minutes
- •History of vomiting within 2 hours of onset of a migraine headache in more than 25% of migraine headaches
- •Medication overuse headache, defined as:
- •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
- •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
- •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
- •Hospital admission for status intractable migraine or medication overuse headache within 6 months of screening
研究组 & 干预措施
Active
Subjects will be given two 30 mg capsules of the investigational medicinal product (LAT8881), and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
干预措施: LAT8881 (Drug)
Placebo
Subjects will be given two capsules of placebo, and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
时间窗: 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Change in migraine headache pain score, using an 11-point numeric rating scale (NRS), (0 = none, 10 = worst imaginable), Pain is recorded in a subject diary and should reflect the subject's pain at the time of recording. A reduction in NRS score indicates a reduction in pain intensity.
次要结局
- Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)(0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose)
- Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)(0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose)
- The Percentage of Subjects Achieving "no Headache Pain"(30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dose)