Back to resultsEfficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine
Primary Purpose
Migraine
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Ketorolac tromethamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine, Ketorolac
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
Sites / Locations
- Volker Pfaffenrath
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Ketorolac tromethamine
Arm Description
Intranasal Placebo
Intranasal ketorolac tromethamine
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00483717
Brief Title
Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egalet Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
Detailed Description
Evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Ketorolac
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intranasal Placebo
Arm Title
Ketorolac tromethamine
Arm Type
Experimental
Arm Description
Intranasal ketorolac tromethamine
Intervention Type
Drug
Intervention Name(s)
Ketorolac tromethamine
Intervention Description
31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intranasal (IN) placebo
Primary Outcome Measure Information:
Title
The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.
Description
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
Time Frame
2 hours after dosing
Secondary Outcome Measure Information:
Title
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Description
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
Time Frame
0.5 hours post-dosing
Title
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Description
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
Time Frame
1 hour post-dosing
Title
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Description
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
Time Frame
1.5 hours post-dosing
Title
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Description
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
Time Frame
3 hours post-dosing
Title
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Description
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
Time Frame
4 hours post-dosing
Title
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Description
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
Time Frame
24 hours post-dosing
Title
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
Description
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
Time Frame
48 hours post-dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Whiting, Ph D
Organizational Affiliation
American Regent, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Volker Pfaffenrath
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80802
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine
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