CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 72 enrolled
Drug / intervention
Ketorolac +2 moredrug
Likely dose
Ketorolac 31.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01807234
NCT01807234Phase 4Completed
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Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine (The KSPN Migraine Study)

Johns Hopkins University·interventional·Posted Mar 8, 2013·Updated Mar 13, 2017

In Brief

A Phase 4 clinical trial evaluating Ketorolac, Sumatriptan, and 1 other intervention for Migraines. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraines
CountriesUnited States
CollaboratorsAmerican Regent, Inc.

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2013
Enrollment StartFeb 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.3 years ago

Interventions

Ketorolacdrug

Single dose of Ketorolac (Sprix) nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.

Sumatriptandrug

Sumatriptan (Imitrex) 20 mg one single dose of nasal spray for an acute migraine attack.

Placebodrug

Placebo one spray in each nostril and placebo one nasal spray.