A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 512
- 主要终点
- Percentage of Participants With Headache Response
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.
详细描述
Migraine is a common chronic neurological disorder characterized by recurrent disabling episodes of moderate to severe headache accompanied by nausea, vomiting, photophobia, and phonophobia. Acute pharmacologic therapy for migraine aims to terminate the attack or reduce its severity. Analgesics are commonly used or, if these are ineffective, triptans. Since triptans are contraindicated in patients with coronary artery disease, uncontrolled hypertension, and cerebrovascular disease alternative medications are required for patients where simple analgesics do not work. COL-144 has no vasoconstrictor activity at clinically relevant concentrations and might meet this need. COL-144 was effective when given intravenously in a placebo-controlled dose-ranging study. This study investigates which dose of oral COL-144 is effective in the in acute treatment of migraine headache.
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
- 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
- •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 patients aged 18 to 65 years
- •Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)
- •Able and willing to give written informed consent
- •Able and willing to complete a migraine diary card to record details of the attack treated with study medication
排除标准
- •History of life threatening or intolerable adverse reaction to any triptan
- •Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
- •Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
- •Using 5-HT reuptake inhibitors
- •Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
- •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)
- •History of orthostatic hypotension
- •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 or hepatic 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
- •Known Hepatitis B or C or HIV infection
- •Patients who are employees of the sponsor
- •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 drug product
- •Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
研究组 & 干预措施
50 mg Lasmiditan
50 mg lasmiditan administered orally (PO)
干预措施: Lasmiditan (Drug)
100 mg Lasmiditan
100 mg lasmiditan administered orally (PO)
干预措施: Lasmiditan (Drug)
200 mg Lasmiditan
200 mg lasmiditan administered orally (PO)
干预措施: Lasmiditan (Drug)
400 mg Lasmiditan
400 mg lasmiditan administered orally (PO)
干预措施: Lasmiditan (Drug)
Placebo
Placebo administered orally (PO)
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Headache Response
时间窗: 2 hours postdose
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 administration of study drug.
次要结局
- Percentage of Participants Who Have Photophobia(2 hours postdose)
- Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)(2 hours postdose)
- Actual Time to Headache Relief and Time to Pain Free(up to 24 hours postdose)
- Change From Baseline in Heart Rate(Baseline through Day 14)
- Percentage of Participants With Headache Recurrence(up to 24 hours postdose)
- Percentage of Participants Who Have Symptoms of Nausea(2 hours postdose)
- Percentage of Participants With Vomiting(2 hours postdose)
- Percentage of Participants Who Used Rescue Medication(Postdose 2 through 24 hours)
- Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose(2 hours post dose)
- Percentage of Participants With Headache Severity (4 Point Rating Scale)(2 hours postdose)
- Percentage of Participants Who Have Symptoms Phonophobia(2 hours postdose)
- Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)(2 hours postdose)
- Change From Baseline in Diastolic Blood Pressure(Baseline through Day 14)
- Percentage of Participants With Change From Baseline in Physical Examination Parameters(Baseline through Day 14)
- Change From Baseline in Hematology Tests(Baseline through Day 14)
- Number of Serious Adverse Events(up to 8 weeks)
- Change From Baseline in Systolic Blood Pressure(Baseline through Day 14)