Trial Outcomes & Findings for Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine (NCT NCT00483717)
NCT ID: NCT00483717
Last Updated: 2016-09-30
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
173 participants
Primary outcome timeframe
2 hours after dosing
Results posted on
2016-09-30
Participant Flow
5 months and 3 weeks; Medical Centers and Hospitals
Participant milestones
| Measure |
Ketorolac Tromethamine
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
86
|
|
Overall Study
COMPLETED
|
63
|
65
|
|
Overall Study
NOT COMPLETED
|
24
|
21
|
Reasons for withdrawal
| Measure |
Ketorolac Tromethamine
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
|---|---|---|
|
Overall Study
Protocol Violation
|
5
|
7
|
|
Overall Study
Time of dosing missing
|
1
|
1
|
|
Overall Study
No treatment for migraine
|
16
|
13
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine
Baseline characteristics by cohort
| Measure |
Ketorolac Tromethamine
n=87 Participants
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
n=86 Participants
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
50 participants
n=5 Participants
|
48 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
37 participants
n=5 Participants
|
38 participants
n=7 Participants
|
75 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours after dosingPopulation: Modified ITT
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
Outcome measures
| Measure |
Ketorolac Tromethamine
n=68 Participants
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
n=72 Participants
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
|---|---|---|
|
The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.
|
12 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 0.5 hours post-dosingPopulation: Modified ITT
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
Outcome measures
| Measure |
Ketorolac Tromethamine
n=68 Participants
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
n=72 Participants
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
|---|---|---|
|
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 1 hour post-dosingPopulation: Modified ITT
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
Outcome measures
| Measure |
Ketorolac Tromethamine
n=68 Participants
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
n=72 Participants
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
|---|---|---|
|
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
|
12 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 1.5 hours post-dosingPopulation: Modified ITT
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
Outcome measures
| Measure |
Ketorolac Tromethamine
n=68 Participants
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
n=72 Participants
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
|---|---|---|
|
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
|
19 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 3 hours post-dosingPopulation: Modified ITT
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
Outcome measures
| Measure |
Ketorolac Tromethamine
n=67 Participants
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
n=72 Participants
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
|---|---|---|
|
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
|
22 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 4 hours post-dosingPopulation: Modified ITT
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
Outcome measures
| Measure |
Ketorolac Tromethamine
n=67 Participants
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
n=72 Participants
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
|---|---|---|
|
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
|
25 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 24 hours post-dosingPopulation: Modified ITT
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
Outcome measures
| Measure |
Ketorolac Tromethamine
n=67 Participants
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
n=72 Participants
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
|---|---|---|
|
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
|
37 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 48 hours post-dosingPopulation: Modified ITT
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
Outcome measures
| Measure |
Ketorolac Tromethamine
n=67 Participants
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
n=72 Participants
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
|---|---|---|
|
The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
|
33 participants
|
15 participants
|
Adverse Events
Ketorolac Tromethamine
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ketorolac Tromethamine
n=69 participants at risk
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
n=73 participants at risk
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
|---|---|---|
|
Nervous system disorders
Hypoaesthesia
|
1.4%
1/69 • Number of events 2 • 5 months and 3 weeks
ITT population
|
0.00%
0/73 • 5 months and 3 weeks
ITT population
|
Other adverse events
| Measure |
Ketorolac Tromethamine
n=69 participants at risk
Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
|
Placebo
n=73 participants at risk
Intranasal Placebo
Placebo : Intranasal (IN) placebo
|
|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
7.2%
5/69 • Number of events 5 • 5 months and 3 weeks
ITT population
|
6.8%
5/73 • Number of events 5 • 5 months and 3 weeks
ITT population
|
|
General disorders
Fatigue
|
5.8%
4/69 • Number of events 4 • 5 months and 3 weeks
ITT population
|
4.1%
3/73 • Number of events 3 • 5 months and 3 weeks
ITT population
|
|
Nervous system disorders
Dizziness
|
5.8%
4/69 • Number of events 4 • 5 months and 3 weeks
ITT population
|
4.1%
3/73 • Number of events 3 • 5 months and 3 weeks
ITT population
|
|
Nervous system disorders
Dysgeusia
|
1.4%
1/69 • Number of events 1 • 5 months and 3 weeks
ITT population
|
5.5%
4/73 • Number of events 4 • 5 months and 3 weeks
ITT population
|
|
Respiratory, thoracic and mediastinal disorders
Intranasal hypoaesthesia
|
7.2%
5/69 • Number of events 5 • 5 months and 3 weeks
ITT population
|
19.2%
14/73 • Number of events 14 • 5 months and 3 weeks
ITT population
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.0%
9/69 • Number of events 9 • 5 months and 3 weeks
ITT population
|
4.1%
3/73 • Number of events 3 • 5 months and 3 weeks
ITT population
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
24.6%
17/69 • Number of events 17 • 5 months and 3 weeks
ITT population
|
2.7%
2/73 • Number of events 2 • 5 months and 3 weeks
ITT population
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hypoaesthesia
|
1.4%
1/69 • Number of events 1 • 5 months and 3 weeks
ITT population
|
8.2%
6/73 • Number of events 6 • 5 months and 3 weeks
ITT population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
10.1%
7/69 • Number of events 7 • 5 months and 3 weeks
ITT population
|
0.00%
0/73 • 5 months and 3 weeks
ITT population
|
Additional Information
David Bregman, M.D., Ph.D
Luitpold Pharmaceuticals, Inc.
Phone: 601-650-4200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place