NCT00384774已完成2 期
A Placebo-Controlled, Group Sequential, Adaptive Treatment Assignment Study of Intravenous COL-144 (LY573144) in the Acute Treatment of 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
- 130
- 主要终点
- Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug
研究概览
简要总结
This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment of migraine headache in order to select a dose range for further studies.
详细描述
This study is set up:
- to evaluate the efficacy (headache response at two hours) of a range of intravenous doses of COL-144 in order to select a dose range for further evaluation,
- to explore the time course and effect of a range of dose levels of COL-144 on features of the migraine including: headache response, proportion of participants pain-free, headache recurrence, nausea, photophobia, phonophobia, disability, use of rescue medication, patient global impression and vomiting
- to explore the safety and tolerability of a range of doses of COL-144 in terms of adverse events, physical exam, vital signs, laboratory evaluations, and ECGs
- to determine key PK parameters for COL-144 and to explore the relationship between the PK of COL-144 and the time course and extent of clinical response
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
- •History of migraine of at least 1 year
- •Migraine onset before the age of 50 years
- •History of 1 - 8 migraine attacks per month
- •Male or female subjects aged 18 to 65 years
- •Female patients of child-bearing potential must be using a highly effective form of contraception (eg combined oral contraceptive, IUD, abstinence, vasectomized partner)
- •Able and willing to return to the clinic for treatment within 4 hours of the onset of a migraine headache
- •Able and willing to give written informed consent
排除标准
- •History of life threatening or intolerable adverse reaction to any triptan
- •Use of prescription migraine prophylactic drugs
- •Pregnant or breast-feeding women
- •Women of child-bearing potential not using highly effective contraception
- •History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
- •History of hypertension (controlled or uncontrolled)
- •Sitting BP >160mmHg systolic or >90mmHg diastolic on 2 repeated measurements at screening
- •Current use of hemodynamically active cardiovascular drugs
- •History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
- •Significant renal impairment
- •Previous participation in this clinical trial
- •Participation in any clinical trial of an experimental drug or device in the previous 30 days
- •Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
- •Relatives of, or staff directly reporting to, the investigator
- •Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144
研究组 & 干预措施
Lasmiditan
Experimental
Participants received escalating doses of 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 45 mg of lasmiditan as intravenous injection.
干预措施: Lasmiditan (Drug)
Placebo
Placebo Comparator
Participants received intravenous infusion of placebo solution.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug
时间窗: 2 hours post dose
Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after initiation of infusion of study drug.
次要结局
- Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose(10, 20, 40, 60 90, 120, 180 and 240 minutes post dose)
- Percentage of Participants Headache Free(10, 20, 40, 60 90, 120, 180 and 240 minutes post dose)
- Number of Participants With Sustained Pain Free(2 to 24 hours post dose)
- Number of Participants With Sustained Headache Response(2 to 24 hours post dose)
- Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia(2 hours post dose)
- Percentage of Participants Using Rescue Medication(24 hours post dose)
- Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)(2 hours post dose)
- Number of Participants With Clinical Disability(2 hours post dose)
研究者
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