Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine (KSPN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01807234
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
American Regent, Inc.
Information provided by (Responsible Party):
Drs Barbara Peterlin, Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraines
Interventions Drug: Ketorolac
Drug: Sumatriptan
Drug: Placebo
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketorolac Then Sumatriptan Then Placebo Kerorolac Then Placebo Then Sumatriptan Sumatriptan Then Ketorolac Then Placebo Sumatriptan Then Placebo Then Ketorolac Placebo Then Ketorolac Then Sumatriptan Placebo Then Sumatriptan Then Ketorolac
Hide Arm/Group Description

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.

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.

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.

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.

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.

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.

Period Title: Overall Study
Started 12 12 12 12 12 12
Randomized, But Did Not Take Drug 3 5 2 1 4 3
Completed Only 1 Attack 2 1 0 1 0 1
Completed 7 6 10 10 8 8
Not Completed 5 6 2 2 4 4
Reason Not Completed
Lost to Follow-up             2             5             1             1             1             2
Withdrawal by Subject             3             1             1             1             2             1
Lack of Efficacy             0             0             0             0             1             1
Arm/Group Title Ketorolac Then Sumatriptan Then Placebo Ketorolac Then Placebo Then Sumatriptan Sumatriptan Then Ketorolac Then Placebo Sumatriptan Then Placebo Then Ketorolac Placebo Then Ketorolac Then Sumatriptan Placebo Then Sumatriptan Then Ketorolac Total
Hide Arm/Group Description

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.

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.

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 12 12 12 12 12 12 72
Hide Baseline Analysis Population Description
Of the 72 randomized participants, 54 (75%) treated at least one attack and 49 (68%) completed all three treatments, for a total of 152 treated migraine attacks.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 72 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
72
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 72 participants
36.3  (9.8) 36.3  (9.8) 36.3  (9.8) 36.3  (9.8) 36.3  (9.8) 36.3  (9.8) 36.3  (9.8)
[1]
Measure Description: Average age of participants
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 72 participants
Female
11
  91.7%
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
11
  91.7%
70
  97.2%
Male
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
2
   2.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 72 participants
12 12 12 12 12 12 72
1.Primary Outcome
Title 2- Hour Pain Relief
Hide Description 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)
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac/ Placebo Sumatriptan/ Placebo Ketorolac Placebo/ Sumatriptan Placebo
Hide Arm/Group Description:

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 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.

Single dose Ketorolac placebo, single dose Sumatriptan placebo

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Overall Number of Participants Analyzed 52 50 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72.5
(59.9 to 85.2)
69.4
(56.0 to 82.8)
38.8
(24.6 to 52.9)
2.Secondary Outcome
Title Pain Freedom
Hide Description 1) 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).
Time Frame 2-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac/ Placebo Sumatriptan/Placebo Ketorolac Placebo/ Sumatriptan Placebo
Hide Arm/Group Description:

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 20 mg single dose nasal spray and placebo

Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Single dose Ketorolac placebo, single dose Sumatriptan placebo

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Overall Number of Participants Analyzed 52 50 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
43.1
(29.1 to 57.2)
36.7
(22.7 to 50.7)
18.4
(7.1 to 29.6)
3.Secondary Outcome
Title Absence of Photophobia
Hide Description 2) Defined as reduction of photophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)
Time Frame 2-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac/ Placebo Sumatriptan/ Placebo Ketorolac Placebo/ Sumatriptan Placebo
Hide Arm/Group Description:

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 20 mg single dose nasal spray and placebo

Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Single dose Ketorolac placebo, single dose Sumatriptan placebo

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Overall Number of Participants Analyzed 52 50 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
65.4
(56.1 to 74.7)
64.0
(54.4 to 73.6)
46.0
(36.1 to 55.9)
4.Secondary Outcome
Title Absence of Phonophobia
Hide Description 3) Defined as reduction of phonophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)
Time Frame 2-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac/ Placebo Sumatriptan/Placebo Ketorolac Placebo/ Sumatriptan Placebo
Hide Arm/Group Description:

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 20 mg single dose nasal spray and placebo

Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Single dose Ketorolac placebo, single dose Sumatriptan placebo

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Overall Number of Participants Analyzed 52 50 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
75.0
(66.5 to 83.4)
66.0
(56.5 to 75.4)
56.0
(46.1 to 65.9)
5.Secondary Outcome
Title Absence of Nausea
Hide Description 4) Defined as reduction of nausea to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)
Time Frame 2-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac/ Placebo Sumatriptan/ Placebo Ketorolac Placebo/ Sumatriptan Placebo
Hide Arm/Group Description:

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 20 mg single dose nasal spray and placebo

Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Single dose Ketorolac placebo, single dose Sumatriptan placebo

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Overall Number of Participants Analyzed 52 50 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
82.7
(75.3 to 90.0)
74.0
(65.2 to 82.7)
66.0
(56.5 to 75.4)
6.Secondary Outcome
Title Absence of Allodynia
Hide Description 5) 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.
Time Frame 2-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac/ Placebo Sumatriptan/ Placebo Ketorolac Placebo/ Sumatriptan Placebo
Hide Arm/Group Description:

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 20 mg single dose nasal spray and placebo

Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Single dose Ketorolac placebo, single dose Sumatriptan placebo

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Overall Number of Participants Analyzed 52 50 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
70.5
(57.6 to 83.5)
75.5
(63.0 to 87.9)
69.0
(57.6 to 83.5)
7.Secondary Outcome
Title Self-assessment of Disability: Percentage of Participants With Moderate or Severe Disability
Hide Description Participants’ 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. .
Time Frame 2-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac/ Placebo Sumatriptan/ Placebo Ketorolac Placebo/ Sumatriptan Placebo
Hide Arm/Group Description:

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 20 mg single dose nasal spray and placebo

Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Single dose Ketorolac placebo, single dose Sumatriptan placebo

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Overall Number of Participants Analyzed 52 50 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
1.9
(0.2 to 13.1)
8.1
(3.0 to 20.1)
10.2
(4.2 to 22.5)
8.Secondary Outcome
Title Sustained Pain Relief (SPR)
Hide Description 7) 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).
Time Frame 24 and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac/ Placebo Sumatriptan/ Placebo Ketorolac Placebo/ Sumatriptan Placebo
Hide Arm/Group Description:

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 20 mg single dose nasal spray and placebo

Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Single dose Ketorolac placebo, single dose Sumatriptan placebo

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Overall Number of Participants Analyzed 52 50 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
24 hour sustained pain relief
49.0
(34.8 to 63.2)
40.8
(26.5 to 55.1)
20.4
(8.7 to 32.1)
48 hour sustained pain relief
49.0
(34.8 to 63.2)
30.6
(17.2 to 43.9)
20.4
(8.7 to 32.1)
9.Secondary Outcome
Title Sustained Pain Freedom (SPF)
Hide Description 8) 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).
Time Frame 24 and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac/ Placebo Sumatriptan/ Placebo Ketorolac Placebo/ Sumatriptan Placebo
Hide Arm/Group Description:

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 20 mg single dose nasal spray and placebo

Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Single dose Ketorolac placebo, single dose Sumatriptan placebo

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Overall Number of Participants Analyzed 52 50 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
24 hour sustained pain freedom
35.3
(21.7 to 48.9)
22.4
(10.3 to 34.5)
12.2
(2.7 to 21.7)
48 hour sustained pain freedom
33.3
(19.9 to 46.7)
18.4
(7.1 to 29.6)
12.2
(2.7 to 21.7)
10.Secondary Outcome
Title Time to Pain Relief
Hide Description 9) 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.
Time Frame following each treated migraine attack
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac/ Placebo Sumatriptan/ Placebo Ketorolac Placebo/ Sumatriptan Placebo
Hide Arm/Group Description:

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 20 mg single dose nasal spray and placebo

Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Single dose Ketorolac placebo, single dose Sumatriptan placebo

Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.

Overall Number of Participants Analyzed 52 50 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
10 minutes
15.7
(5.3 to 26.0)
14.3
(4.1 to 24.4)
12.2
(2.7 to 21.7)
15 minutes
35.3
(21.7 to 48.8)
36.0
(22.2 to 49.7)
14.3
(4.1 to 24.4)
20 minutes
43.1
(29.1 to 57.2)
44.9
(30.4 to 59.3)
22.4
(10.3 to 34.5)
30 minutes
54.9
(40.7 to 69.0)
53.1
(38.6 to 67.5)
26.5
(13.7 to 39.3)
1 hour
58.8
(44.8 to 72.8)
57.1
(42.8 to 71.5)
32.6
(19.0 to 46.2)
Time Frame 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.
Adverse Event Reporting Description At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.
 
Arm/Group Title Sprix/Placebo Sumatriptan/Placebo SRIX Placebo/Sumatriptan Placebo
Hide Arm/Group Description

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 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%).

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%).

All-Cause Mortality
Sprix/Placebo Sumatriptan/Placebo SRIX Placebo/Sumatriptan Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sprix/Placebo Sumatriptan/Placebo SRIX Placebo/Sumatriptan Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/50 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sprix/Placebo Sumatriptan/Placebo SRIX Placebo/Sumatriptan Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/52 (82.69%)   39/50 (78.00%)   11/50 (22.00%) 
Gastrointestinal disorders       
nausea  1  1/52 (1.92%)  4/50 (8.00%)  2/50 (4.00%) 
General disorders       
fatigue  1  2/52 (3.85%)  2/50 (4.00%)  2/50 (4.00%) 
Nervous system disorders       
mild unusual taste  1  1/52 (1.92%)  12/50 (24.00%)  2/50 (4.00%) 
moderate unusual taste  1  3/52 (5.77%)  6/50 (12.00%)  1/50 (2.00%) 
severe unusual taste  1  1/52 (1.92%)  2/50 (4.00%)  0/50 (0.00%) 
dizziness  1  2/52 (3.85%)  2/50 (4.00%)  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders       
mild burning of nose  1  13/52 (25.00%)  3/50 (6.00%)  1/50 (2.00%) 
moderate burning of nose  1  10/52 (19.23%)  1/50 (2.00%)  0/50 (0.00%) 
severe burning of nose  1  2/52 (3.85%)  0/50 (0.00%)  0/50 (0.00%) 
nasal discomfort  1  4/52 (7.69%)  3/50 (6.00%)  0/50 (0.00%) 
burning of throat  1  3/52 (5.77%)  3/50 (6.00%)  0/50 (0.00%) 
Skin and subcutaneous tissue disorders       
rash  1  1/52 (1.92%)  1/50 (2.00%)  2/50 (4.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedWatch
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. B. Lee Peterlin
Organization: Johns Hopkins University School of Medicine
Phone: 410-550-9550
EMail: hnitchi1@jhmi.edu
Layout table for additonal information
Responsible Party: Drs Barbara Peterlin, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01807234     History of Changes
Other Study ID Numbers: NA00075486
First Submitted: March 6, 2013
First Posted: March 8, 2013
Results First Submitted: January 27, 2016
Results First Posted: March 13, 2017
Last Update Posted: March 13, 2017