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

NCT00483717 | Completed Phase 2 Results

• 1 other identifier: ROX-2007-01
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine

Keywords

Migraine; Ketorolac

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point

  0.5 hours post-dosing

• The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point

  1 hour post-dosing

• The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point

  1.5 hours post-dosing

• The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point

  3 hours post-dosing

• The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point

  4 hours post-dosing

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Intranasal Placebo

Drug: Placebo

Ketorolac tromethamine

EXPERIMENTAL

Intranasal ketorolac tromethamine

Drug: Ketorolac tromethamine

Interventions

Ketorolac tromethamine DRUG

31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)

Ketorolac tromethamine

Placebo DRUG

Intranasal (IN) placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Egalet Ltd: lead

Study Sites (1)

Volker Pfaffenrath

Munich, Bavaria, 80802, Germany

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: David Bregman, M.D., Ph.D
• Organization: Luitpold Pharmaceuticals, Inc.

dbregman@lpicrd.com

601-650-4200

Study Officials

• Roger Whiting, Ph D

  American Regent, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2007
• First Posted: June 7, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 30, 2016
• Results First Posted: September 30, 2016

Record last verified: 2016-09

Locations

DE (1)