Migraine
Conditions
Keywords
Migraine, Ketorolac
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.
Interventions
DRUGKetorolac tromethamine
31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
DRUGPlacebo
Intranasal (IN) placebo
Sponsors
Egalet Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point. | 2 hours after dosing | 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
| Measure | Time frame | Description |
|---|---|---|
| The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 0.5 hours post-dosing | 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 |
Countries
Germany
Participant flow
Recruitment details
5 months and 3 weeks; Medical Centers and Hospitals
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac Tromethamine Intranasal ketorolac tromethamine
Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride) | 87 |
| Placebo Intranasal Placebo
Placebo : Intranasal (IN) placebo | 86 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | No treatment for migraine | 16 | 13 |
| Overall Study | Protocol Violation | 5 | 7 |
| Overall Study | Time of dosing missing | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Ketorolac Tromethamine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants | 84 Participants | 171 Participants |
| Age, Continuous | 38.2 years STANDARD_DEVIATION 11.4 | 38.5 years STANDARD_DEVIATION 11.6 | 38.3 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment Finland | 37 participants | 38 participants | 75 participants |
| Region of Enrollment Germany | 50 participants | 48 participants | 98 participants |
| Sex: Female, Male Female | 82 Participants | 76 Participants | 158 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 53 / 69 | 40 / 73 |
| serious Total, serious adverse events | 1 / 69 | 0 / 73 |
Outcome results
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
Time frame: 2 hours after dosing
Population: Modified ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac Tromethamine | The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point. | 12 participants |
| Placebo | The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point. | 7 participants |
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
Time frame: 0.5 hours post-dosing
Population: Modified ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac Tromethamine | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 2 participants |
| Placebo | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 1 participants |
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
Time frame: 1 hour post-dosing
Population: Modified ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac Tromethamine | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 12 participants |
| Placebo | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 4 participants |
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
Time frame: 1.5 hours post-dosing
Population: Modified ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac Tromethamine | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 19 participants |
| Placebo | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 6 participants |
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
Time frame: 3 hours post-dosing
Population: Modified ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac Tromethamine | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 22 participants |
| Placebo | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 10 participants |
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
Time frame: 4 hours post-dosing
Population: Modified ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac Tromethamine | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 25 participants |
| Placebo | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 11 participants |
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
Time frame: 24 hours post-dosing
Population: Modified ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac Tromethamine | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 37 participants |
| Placebo | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 18 participants |
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
Time frame: 48 hours post-dosing
Population: Modified ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac Tromethamine | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 33 participants |
| Placebo | The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point | 15 participants |