Trial Outcomes & Findings for Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine (NCT NCT01807234)
NCT ID: NCT01807234
Last Updated: 2017-03-13
Results Overview
The primary outcome was 2-hour headache relief; headache relief was defined as headache pain from moderate or severe pain to none or mild pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
2 hours
Results posted on
2017-03-13
Participant Flow
Participant milestones
| Measure |
Ketorolac Then Sumatriptan Then Placebo
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
|
Kerorolac Then Placebo Then Sumatriptan
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
|
Sumatriptan Then Ketorolac Then Placebo
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
|
Sumatriptan Then Placebo Then Ketorolac
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
|
Placebo Then Ketorolac Then Sumatriptan
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
|
Placebo Then Sumatriptan Then Ketorolac
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
12
|
12
|
|
Overall Study
Randomized, But Did Not Take Drug
|
3
|
5
|
2
|
1
|
4
|
3
|
|
Overall Study
Completed Only 1 Attack
|
2
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
COMPLETED
|
7
|
6
|
10
|
10
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
2
|
2
|
4
|
4
|
Reasons for withdrawal
| Measure |
Ketorolac Then Sumatriptan Then Placebo
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
|
Kerorolac Then Placebo Then Sumatriptan
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
|
Sumatriptan Then Ketorolac Then Placebo
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
|
Sumatriptan Then Placebo Then Ketorolac
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
|
Placebo Then Ketorolac Then Sumatriptan
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
|
Placebo Then Sumatriptan Then Ketorolac
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
1
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
1
|
1
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine
Baseline characteristics by cohort
| Measure |
Ketorolac Then Sumatriptan Then Placebo
n=12 Participants
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
|
Ketorolac Then Placebo Then Sumatriptan
n=12 Participants
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
|
Sumatriptan Then Ketorolac Then Placebo
n=12 Participants
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
|
Sumatriptan Then Placebo Then Ketorolac
n=12 Participants
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
|
Placebo Then Ketorolac Then Sumatriptan
n=12 Participants
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
|
Placebo Then Sumatriptan Then Ketorolac
n=12 Participants
Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.
Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.
Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.
Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
72 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
36.3 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
36.3 years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
36.3 years
STANDARD_DEVIATION 9.8 • n=8 Participants
|
36.3 years
STANDARD_DEVIATION 9.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
70 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
12 participants
n=21 Participants
|
12 participants
n=8 Participants
|
72 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 2 hoursThe primary outcome was 2-hour headache relief; headache relief was defined as headache pain from moderate or severe pain to none or mild pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe)
Outcome measures
| Measure |
Ketorolac/ Placebo
n=52 Participants
Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Sumatriptan/ Placebo
n=50 Participants
Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Ketorolac Placebo/ Sumatriptan Placebo
n=50 Participants
Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
|---|---|---|---|
|
2- Hour Pain Relief
|
72.5 percentage of participants
Interval 59.9 to 85.2
|
69.4 percentage of participants
Interval 56.0 to 82.8
|
38.8 percentage of participants
Interval 24.6 to 52.9
|
SECONDARY outcome
Timeframe: 2-hours1\) Pain Freedom: Pain Freedom at 2 hours is defined as being free of pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).
Outcome measures
| Measure |
Ketorolac/ Placebo
n=52 Participants
Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Sumatriptan/ Placebo
n=50 Participants
Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Ketorolac Placebo/ Sumatriptan Placebo
n=50 Participants
Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
|---|---|---|---|
|
Pain Freedom
|
43.1 percentage of patients
Interval 29.1 to 57.2
|
36.7 percentage of patients
Interval 22.7 to 50.7
|
18.4 percentage of patients
Interval 7.1 to 29.6
|
SECONDARY outcome
Timeframe: 2-hours2\) Defined as reduction of photophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)
Outcome measures
| Measure |
Ketorolac/ Placebo
n=52 Participants
Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Sumatriptan/ Placebo
n=50 Participants
Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Ketorolac Placebo/ Sumatriptan Placebo
n=50 Participants
Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
|---|---|---|---|
|
Absence of Photophobia
|
65.4 percentage of patients
Interval 56.1 to 74.7
|
64.0 percentage of patients
Interval 54.4 to 73.6
|
46.0 percentage of patients
Interval 36.1 to 55.9
|
SECONDARY outcome
Timeframe: 2-hours3\) Defined as reduction of phonophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)
Outcome measures
| Measure |
Ketorolac/ Placebo
n=52 Participants
Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Sumatriptan/ Placebo
n=50 Participants
Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Ketorolac Placebo/ Sumatriptan Placebo
n=50 Participants
Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
|---|---|---|---|
|
Absence of Phonophobia
|
75.0 percentage of patients
Interval 66.5 to 83.4
|
66.0 percentage of patients
Interval 56.5 to 75.4
|
56.0 percentage of patients
Interval 46.1 to 65.9
|
SECONDARY outcome
Timeframe: 2-hours4\) Defined as reduction of nausea to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)
Outcome measures
| Measure |
Ketorolac/ Placebo
n=52 Participants
Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Sumatriptan/ Placebo
n=50 Participants
Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Ketorolac Placebo/ Sumatriptan Placebo
n=50 Participants
Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
|---|---|---|---|
|
Absence of Nausea
|
82.7 percentage of patients
Interval 75.3 to 90.0
|
74.0 percentage of patients
Interval 65.2 to 82.7
|
66.0 percentage of patients
Interval 56.5 to 75.4
|
SECONDARY outcome
Timeframe: 2-hours5\) Absence of allodynia The presence of allodynia was assessed based on a series of 8 questions inquiring as to the presence of allodynia. Participants answering 2 or more questions positively were considered to have allodynia.
Outcome measures
| Measure |
Ketorolac/ Placebo
n=52 Participants
Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Sumatriptan/ Placebo
n=50 Participants
Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Ketorolac Placebo/ Sumatriptan Placebo
n=50 Participants
Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
|---|---|---|---|
|
Absence of Allodynia
|
70.5 percentage of patients
Interval 57.6 to 83.5
|
75.5 percentage of patients
Interval 63.0 to 87.9
|
69.0 percentage of patients
Interval 57.6 to 83.5
|
SECONDARY outcome
Timeframe: 2-hoursParticipants' self-assessment of disability was assessed using 4-point scales (none, mild, moderate, and severe). A binary outcome variable was created grouping none and mild vs moderate to severe. .
Outcome measures
| Measure |
Ketorolac/ Placebo
n=52 Participants
Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Sumatriptan/ Placebo
n=50 Participants
Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Ketorolac Placebo/ Sumatriptan Placebo
n=50 Participants
Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
|---|---|---|---|
|
Self-assessment of Disability: Percentage of Participants With Moderate or Severe Disability
|
1.9 percentage of patients
Interval 0.2 to 13.1
|
8.1 percentage of patients
Interval 3.0 to 20.1
|
10.2 percentage of patients
Interval 4.2 to 22.5
|
SECONDARY outcome
Timeframe: 24 and 48 hours7\) 24 and 48 hours sustained pain relief (SPR) Defined as the reduction of pain to none or mild from moderate or severe, on a 4-point scale (none, mild, moderate, and severe).
Outcome measures
| Measure |
Ketorolac/ Placebo
n=52 Participants
Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Sumatriptan/ Placebo
n=50 Participants
Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Ketorolac Placebo/ Sumatriptan Placebo
n=50 Participants
Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
|---|---|---|---|
|
Sustained Pain Relief (SPR)
48 hour sustained pain relief
|
49.0 percentage of patients
Interval 34.8 to 63.2
|
30.6 percentage of patients
Interval 17.2 to 43.9
|
20.4 percentage of patients
Interval 8.7 to 32.1
|
|
Sustained Pain Relief (SPR)
24 hour sustained pain relief
|
49.0 percentage of patients
Interval 34.8 to 63.2
|
40.8 percentage of patients
Interval 26.5 to 55.1
|
20.4 percentage of patients
Interval 8.7 to 32.1
|
SECONDARY outcome
Timeframe: 24 and 48 hours8\) 24 and 48 hours sustained pain freedom (SPF); Defined as the reduction of pain to none. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).
Outcome measures
| Measure |
Ketorolac/ Placebo
n=52 Participants
Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Sumatriptan/ Placebo
n=50 Participants
Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Ketorolac Placebo/ Sumatriptan Placebo
n=50 Participants
Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
|---|---|---|---|
|
Sustained Pain Freedom (SPF)
24 hour sustained pain freedom
|
35.3 percentage of patients
Interval 21.7 to 48.9
|
22.4 percentage of patients
Interval 10.3 to 34.5
|
12.2 percentage of patients
Interval 2.7 to 21.7
|
|
Sustained Pain Freedom (SPF)
48 hour sustained pain freedom
|
33.3 percentage of patients
Interval 19.9 to 46.7
|
18.4 percentage of patients
Interval 7.1 to 29.6
|
12.2 percentage of patients
Interval 2.7 to 21.7
|
SECONDARY outcome
Timeframe: following each treated migraine attack9\) The time, in minutes, will be measured from the time study drug is taken to the time when significant pain relief is first observed and maintained through 2 hours with no rescue medication use at or prior to this point.
Outcome measures
| Measure |
Ketorolac/ Placebo
n=52 Participants
Ketorolac 31.5 mg single dose nasal spray and Placebo
Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Sumatriptan/ Placebo
n=50 Participants
Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
Ketorolac Placebo/ Sumatriptan Placebo
n=50 Participants
Single dose Ketorolac placebo, single dose Sumatriptan placebo
Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
|
|---|---|---|---|
|
Time to Pain Relief
30 minutes
|
54.9 percentage of patients
Interval 40.7 to 69.0
|
53.1 percentage of patients
Interval 38.6 to 67.5
|
26.5 percentage of patients
Interval 13.7 to 39.3
|
|
Time to Pain Relief
10 minutes
|
15.7 percentage of patients
Interval 5.3 to 26.0
|
14.3 percentage of patients
Interval 4.1 to 24.4
|
12.2 percentage of patients
Interval 2.7 to 21.7
|
|
Time to Pain Relief
15 minutes
|
35.3 percentage of patients
Interval 21.7 to 48.8
|
36.0 percentage of patients
Interval 22.2 to 49.7
|
14.3 percentage of patients
Interval 4.1 to 24.4
|
|
Time to Pain Relief
20 minutes
|
43.1 percentage of patients
Interval 29.1 to 57.2
|
44.9 percentage of patients
Interval 30.4 to 59.3
|
22.4 percentage of patients
Interval 10.3 to 34.5
|
|
Time to Pain Relief
1 hour
|
58.8 percentage of patients
Interval 44.8 to 72.8
|
57.1 percentage of patients
Interval 42.8 to 71.5
|
32.6 percentage of patients
Interval 19.0 to 46.2
|
Adverse Events
Sprix/Placebo
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Sumatriptan/Placebo
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
SRIX Placebo/Sumatriptan Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sprix/Placebo
n=52 participants at risk
Sprix 31.5 mg single dose nasal spray and Placebo
SPRIX: Single dose of Sprix nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
The most common adverse events reported by participants treated with ketorolac NS were burning of nose, (mild in 25.5%, moderate in 19.6% and severe in 3.9%), unusual taste (mild in 2%, moderate in 5.9%, severe 2%), nasal discomfort (8%), burning of throat (6%), fatigue (4%), dizziness (4%), nausea (2%), rash (2%).
|
Sumatriptan/Placebo
n=50 participants at risk
Sumatriptan 20 mg single dose nasal spray and placebo
Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
For those treated with sumatriptan NS the most common adverse events were unusual taste (mild in 24.5%, moderate in 12.2%, severe 4.1%), burning of the nose (mild in 6.1%, moderate in 2%), nausea (8%), burning of the throat (6%), nasal discomfort (6%), dizziness (4%), fatigue (4%) and rash (2%).
|
SRIX Placebo/Sumatriptan Placebo
n=50 participants at risk
single dose SPRIX placebo, single dose Sumatriptan placebo
Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.
The most common adverse event for placebo were unusual taste (mild in 4%, moderate in 2%), nausea (4%), rash (4%), fatigue (4%), burning of the nose (2%), dizziness (2%).
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
mild burning of nose
|
25.0%
13/52 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
6.0%
3/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
2.0%
1/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
|
Respiratory, thoracic and mediastinal disorders
moderate burning of nose
|
19.2%
10/52 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
2.0%
1/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
0.00%
0/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
|
Respiratory, thoracic and mediastinal disorders
severe burning of nose
|
3.8%
2/52 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
0.00%
0/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
0.00%
0/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
|
Nervous system disorders
mild unusual taste
|
1.9%
1/52 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
24.0%
12/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
4.0%
2/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
|
Nervous system disorders
moderate unusual taste
|
5.8%
3/52 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
12.0%
6/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
2.0%
1/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
|
Nervous system disorders
severe unusual taste
|
1.9%
1/52 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
4.0%
2/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
0.00%
0/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
|
Respiratory, thoracic and mediastinal disorders
nasal discomfort
|
7.7%
4/52 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
6.0%
3/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
0.00%
0/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
|
Respiratory, thoracic and mediastinal disorders
burning of throat
|
5.8%
3/52 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
6.0%
3/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
0.00%
0/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
|
General disorders
fatigue
|
3.8%
2/52 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
4.0%
2/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
4.0%
2/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
|
Nervous system disorders
dizziness
|
3.8%
2/52 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
4.0%
2/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
2.0%
1/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
|
Gastrointestinal disorders
nausea
|
1.9%
1/52 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
8.0%
4/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
4.0%
2/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
|
Skin and subcutaneous tissue disorders
rash
|
1.9%
1/52 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
2.0%
1/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
4.0%
2/50 • Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.
At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
|
Additional Information
Dr. B. Lee Peterlin
Johns Hopkins University School of Medicine
Phone: 410-550-9550
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place