Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine

Completed · Phase 4 · Has a placebo group

Conditions studied: Migraines

In brief

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.

Key facts

Study ID

NCT01807234

Run by

Johns Hopkins University

People needed

72

Starts

2013-02-01

Expected to finish

2014-12-01

Last updated by the study team

2017-03-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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 9.
• 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.

Where it is running

• The Johns Hopkins Bayview Headache Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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