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

Phase 4 Completed 72 enrolled Johns Hopkins University American Regent, Inc. · collab

RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start: 2013-02
Primary completion: 2014-12
Completion: 2014-12

Outcome

Met primary endpoint

paper Both ketorolac NS (72.5%, P < .001) and sumatriptan NS (69.4%, P = .001) were more effective than placebo (38.3%) for 2-hour pain relief PMID 26840902 ↗

Publications

Rao AS, Gelaye B, Kurth T, Dash PD, Nitchie H, Peterlin BL. A Randomized Trial of Ketorolac vs. Sumatripan vs. Placebo Nasal Spray (KSPN) for Acute Migraine. Headache. 2016 Feb;56(2):331-40. doi: 10.1111/head.12767. Epub 2016 Feb 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketorolac	Other / unclassified	31.5 mg	Intranasal
Subject	Sumatriptan	Unknown	20 mg	Intranasal