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

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraines

Intervention: SPRIX (Drug); Sumatriptan (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Johns Hopkins University

Summary

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.

Clinical Details

Official title: A Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Efficacy of Ketorolac Nasal Spray (Sprix®) as Compared to Sumatriptan Nasal Spray and Placebo for the Acute Abortive Treatment of Migraine

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Primary endpoints will be proportion of patients who achieve pain relief from moderate to severe to no or mild pain at 2 hours.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion/Exclusion Criteria At the Screening Visit, a subject must meet the following criteria to participate in this study: 1. 18-65 years of age 2. Fulfills International Classification of Headache Disorders (ICHD)-II Criteria of migraine as noted below in Table 1 3. History of migraines for at least one year 4. Migraine onset prior to the age of 50 years of age 5. Headache frequency (of any headaches, migraine or non-migraine) < 9 days per month 6. At visit 2, participants must report between 1-9 migraine attacks during the 28-day run-in period on the headache diary. 7. At least 48 hours of freedom from headache between treated migraine attacks. 8. If currently using headache preventive medications, must be on a stable dose for at least 3 months prior to enrollment and throughout the study period and be on no more than one prophylactic agent. 9. Able to complete all study procedures, including the questionnaire (assessing demographics, headache characteristics, headache comorbidities and medical history at the initial visit and headache characteristics) and the required headache calendars, and all study visits; 10. Able to understand, read and sign an informed consent (English). Exclusion Criteria: 1. 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 2. Physician diagnosis of any pain syndrome other than migraine 3. Classification as treatment resistant by investigator 4. Known drug or substance abuse 5. Any opioid use in past 2 months 6. Use of any medication, which could interfere with study assessments 7. History of noncompliance with taking medication; 8. Use of any experimental drug or device within 30 days prior to the Screening Visit (Visit 1); 9. 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. 10. Any history of chronic renal or hepatic disease already excluded above under number 1; plus see exclusion 9. 11. History of chronic pulmonary disorder including nasal polyps (see 1) and asthma. 12. 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). 13. History of nasal surgery.

Locations and Contacts

The Johns Hopkins Bayview Headache Center, Baltimore, Maryland 21224, United States
Additional Information

Starting date: March 2013
Last updated: June 22, 2015

Page last updated: August 23, 2015

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