Phase 2 Completed N=173 Randomized Double-blind Treatment

Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine

Migraine

Source: ClinicalTrials.gov NCT00483717 ↗

Enrolled (actual)

173

Serious AEs

0.7%

Results posted

Sep 2016

Primary outcomePrimary: The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point. — 12; 7 participants

Summary

The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.	12; 7	—
SECONDARY The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	33; 15	—
SECONDARY The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	33; 15	—
SECONDARY The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	33; 15	—
SECONDARY The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	33; 15	—
SECONDARY The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	33; 15	—
SECONDARY The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	33; 15	—
SECONDARY The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	33; 15	—

Eligibility Criteria

Inclusion Criteria

Diagnosis of migraine with or without aura (IHS criteria 1.1 and 1.2.1);
Onset of migraine prior to age 50;
2-8 moderate to severe migraine headaches per month

Exclusion Criteria

Subjects receiving any investigational drug within 30 days before study entry;
More than 15 headache days per month;
Known allergy or hypersensitivity to ketorolac and/or excipients;
Allergy to aspirin or other NSAIDs;
Currently receiving other NSAIDs or aspirin;
Medical history that would preclude NSAID use

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00483717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.