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

Migraine Clinical Trial

Official title:

A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Analgesic Efficacy of Ketorolac Tromethamine Administered Intranasally for the Acute Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483717
• Other study ID #: ROX-2007-01
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2007
• Last updated: September 22, 2016
• Start date: July 2007
• Est. completion date: January 2008

Study information

• Verified date: September 2016
• Source: Egalet Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Ketorolac tromethamine
31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
• Placebo
Intranasal (IN) placebo

Locations

Country	Name	City	State
Germany	Volker Pfaffenrath	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Egalet Ltd

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.	Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain	2 hours after dosing	No
Secondary	The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain	0.5 hours post-dosing	No
Secondary	The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain	1 hour post-dosing	No
Secondary	The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain	1.5 hours post-dosing	No
Secondary	The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain	3 hours post-dosing	No
Secondary	The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain	4 hours post-dosing	No
Secondary	The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain	24 hours post-dosing	No
Secondary	The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point	Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain	48 hours post-dosing	No