NCT00242866已完成2 期
A Multicentre, Two-part, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Tolerability and Pharmacokinetics of the iNOS Inhibitor GW274150 Administered up to 120mg Daily for 12 Weeks in the Prophylactic 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
- 430
- 试验地点
- 1
- 主要终点
- Occurrence of a migraine headache day on each day during the 4-week baseline period and the 12-week treatment period.
研究概览
简要总结
Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of NOS, and therefore NO, may be an effective technique for the prevention of migraine headache. GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory activity in migraine through a novel mechanism of action. The intent of this study is to investigate the safety and efficacy of GW274150 for the prophylactic 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
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Suffering from migraine with or without aura.
- •Migraine for at least one year, and the age of onset was prior to 50 years.
- •Consistent migraine headache over time and has had at least 3 migraine headache attacks but less than 15 days with headache (migraine or non-migraine) per month in each of the three months prior to the Screening Visit and maintains this requirement during the baseline period.
- •Able to distinguish migraine headache attacks as discreet attacks from other headaches (i.e. tension-type headaches).
- •No clinically significant abnormality identified on the medical or laboratory evaluation. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the doctor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- •Written informed consent prior to entry into the study.
- •Females who are: a) non-childbearing potential or, b) of child-bearing potential, has a negative pregnancy test at screen, and is taken adequate contraceptive measures.
排除标准
- •As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.
- •Headache for 15 days per month or greater in any of the three months (90 days) preceding the Screening Visit.
- •History of alcohol, substance or drug abuse within the last year.
- •Taken a migraine prophylactic medication within 1 month of the Screening Visit.
- •Uses an opiate as first line acute treatment for migraine attacks.
- •History of ergotamine, triptan, opioid, or combination medication intake on greater than/equal 10 days per month on a regular basis for greater than/equal 3 months.
- •History of simple analgesic intake on greater than/equal 15 days per month for greater than/equal 3 months.
- •Failed two or more adequate treatments of migraine prophylaxis, where failure is defined as a lack of efficacy with a treatment duration of at least 8 weeks or withdrawal of treatment due to treatment intolerance.
- •Uncontrolled hypertension at the Screening Visit, defined as systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg.
- •Taking cyclosporine and/or aminoglycosides.
- •Evidence of renal impairment - calculated creatinine clearance <60ml/min or clinically relevant finding on urinalysis.
- •History of drug or other allergy which, in the opinion of the doctor, makes the subject unsuitable for participation in the study.
- •Concurrently participating in another clinical study or investigational drug trial or has participated within the previous 3 months or is planning to participate in another drug or device study at any time during this study (screening through follow-up) or has had previous exposure to GW274150 in Part 1 of the study.
- •Felt to be at risk of non-compliance (for taking study medication or for completing the electronic diary (e-diary)), in the doctor's opinion.
- •Pregnant or nursing women.
- •History of, or risk factors for, HIV, Hepatitis B and Hepatitis C.
- •Past or present disease, which as judged by the doctor, may affect the outcome of this study. These diseases include, but are not limited to history of liver or renal disease in the 6 months prior to screening.
- •Clinically significant abnormalities in safety laboratory analysis at the Screening Visit, particularly any abnormal liver or pancreatic function test at the Screening Visit.
- •Not covered by social security.
研究组 & 干预措施
Arm 1
Experimental
GW274150 - 5mg or 30mg
干预措施: GW274150 (Drug)
Arm 1
Experimental
GW274150 - 5mg or 30mg
干预措施: Placebo (Other)
Arm 2
Placebo Comparator
Placebo to match GW274150
干预措施: GW274150 (Drug)
Arm 2
Placebo Comparator
Placebo to match GW274150
干预措施: Placebo (Other)
结局指标
主要结局
Occurrence of a migraine headache day on each day during the 4-week baseline period and the 12-week treatment period.
时间窗: 12 Weeks
次要结局
- Change from baseline in the number of migraine headache days, migraine attacks, mean peak migraine pain severity and mean migraine headache duration for each 4 week treatment period and over the entire treatment period.(12 Weeks)
研究者
研究点 (1)
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