Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine (The KSPN Migraine Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 2- Hour Pain Relief
研究概览
简要总结
The investigators propose to test the efficacy of ketorolac nasal spray versus sumatriptan nasal spray versus placebo for acute abortive therapy of migraine head pain as well as for migraine associated symptoms including nausea and allodynia.
详细描述
Participants are randomized to Ketorolac NS 31.5 mg, Sumatriptan NS 20 mg or placebo to treat three moderate to severe migraine attacks and switched treatments with each attack so that they received each treatment only once.
For each treated attack (moderate to severe migraine attack), participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
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
- 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
- 未提供
排除标准
- •Any condition (history or presence of) which contraindicates the use of triptans or NSAIDs including:
- •Known hypersensitivity or intolerance to triptans or NSAIDs
- •Contraindications to triptan use (uncontrolled hypertension, ischemic heart disease, prinz-metal angina, cardiac arrhythmias, multiple risk factors for atherosclerotic vascular disease, primary vasculopathies, and basilar and hemiplegic migraine)
- •Cerebrovascular disease except for mild non-specific white matter disease
- •Peripheral vascular disease or any other ischemic disease including myocardial infarction
- •Uncontrolled hypertension (systolic BP 160 mmHg or diastolic BP 95 mmHg or (both)
- •Migraine aura fulfilling ICHD-II criteria for hemiplegic or basilar-type migraine
- •Any history of chronic renal or hepatic impairment
- •Use of an ergotamine-containing medication or monamine oxidase inhibitor
- •Known or suspected pregnancy, negative pregnancy test
- •Lactation
- •Bleeding dsycrasias including gastritis, peptic ulcer disease,gastrointestinal bleeding
- •Physician diagnosis of any pain syndrome other than migraine
- •Classification as treatment resistant by investigator
- •Known drug or substance abuse
- •Any opioid use in past 2 months
- •Use of any medication, which could interfere with study assessments
- •History of noncompliance with taking medication;
- •Use of any experimental drug or device within 30 days prior to the Screening Visit (Visit 1);
- •Any abnormal finding or condition deemed clinically significant by the investigator on history, screening, or physical exam that contraindicates the use of triptans or NSAIDs or that might interfere with the patient's safety, study participation, or which might confound the interpretation of the study results.
- •Any history of chronic renal or hepatic disease already excluded above under number 1; plus see exclusion
- •History of chronic pulmonary disorder including nasal polyps (see 1) and asthma.
- •History of upper respiratory infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with assessment of AEs including rhinitis medicamentosa (chronic daily use of topical decongestants).
- •History of nasal surgery.
研究组 & 干预措施
Ketorolac/Placebo
Ketorolac 31.5 mg single dose nasal spray and Placebo
干预措施: Placebo (Drug)
Ketorolac/Placebo
Ketorolac 31.5 mg single dose nasal spray and Placebo
干预措施: Ketorolac (Drug)
Sumatriptan/Placebo
Sumatriptan 20 mg single dose nasal spray and placebo
干预措施: Sumatriptan (Drug)
Sumatriptan/Placebo
Sumatriptan 20 mg single dose nasal spray and placebo
干预措施: Placebo (Drug)
Ketorolac Placebo/Sumatriptan placebo
single dose Ketorolac placebo, single dose Sumatriptan placebo
干预措施: Placebo (Drug)
结局指标
主要结局
2- Hour Pain Relief
时间窗: 2 hours
The primary outcome was 2-hour headache relief; headache relief was defined as headache pain from moderate or severe pain to none or mild pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe)
次要结局
- Absence of Nausea(2-hours)
- Sustained Pain Relief (SPR)(24 and 48 hours)
- Absence of Photophobia(2-hours)
- Absence of Allodynia(2-hours)
- Absence of Phonophobia(2-hours)
- Self-assessment of Disability: Percentage of Participants With Moderate or Severe Disability(2-hours)
- Time to Pain Relief(following each treated migraine attack)
- Pain Freedom(2-hours)
- Sustained Pain Freedom (SPF)(24 and 48 hours)
研究者
Drs Barbara Peterlin
Director, The Johns Hopkins Bayview Headache Research
Johns Hopkins University