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Trial record 5 of 179 for:    Migraine AND migraine with or without aura

Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura (COMPASS)

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ClinicalTrials.gov Identifier: NCT01667679
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : March 14, 2017
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Migraine
Headaches
Interventions Drug: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
Drug: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
Enrollment 275
Recruitment Details  
Pre-assignment Details A total of 334 participants were assessed for eligibility; of these, 275 participants were randomized.
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description In Treatment Period (TP) 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2. In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Period Title: Treatment Period 1 (<=12 Weeks)
Started 138 137
Completed 122 107
Not Completed 16 30
Reason Not Completed
Failure to Treat Migraine Headache             2             6
Dosed Incorrectly             2             0
Lack of Efficacy             2             0
Could Not Tolerate Diary             1             0
Withdrawal by Subject             6             13
Adverse Event             3             3
Lost to Follow-up             0             2
Protocol Violation             0             2
Non-compliance             0             3
Moved Out of State             0             1
Period Title: Treatment Period 2 (<=12 Weeks)
Started 122 107
Completed 100 85
Not Completed 22 22
Reason Not Completed
Withdrawal by Subject             6             4
Non-compliance with Electronic Diary             2             0
Lost to Follow-up             8             10
Non-compliance             3             4
Sponsor Decision             1             0
Failure to Treat Migraine Headache             1             0
Adverse Event             1             0
Significant Improvement in Migraine             0             1
Partially Dosed             0             1
Brought in before 12 Weeks/5 Migraines             0             1
Refused Last Day of Visit 4 Procedures             0             1
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) Total
Hide Arm/Group Description In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1, participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1, participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Total of all reporting groups
Overall Number of Baseline Participants 133 129 262
Hide Baseline Analysis Population Description
Baseline data are reported for participants in the Safety Analysis Set, defined as all randomized participants who received at least one dose of sumatriptan (20 mg nasal powder or 100 mg tablet).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 129 participants 262 participants
39.5  (12.55) 40.7  (11.93) 40.1  (12.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 129 participants 262 participants
Female
107
  80.5%
115
  89.1%
222
  84.7%
Male
26
  19.5%
14
  10.9%
40
  15.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 129 participants 262 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   2.3%
1
   0.8%
4
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
24
  18.0%
26
  20.2%
50
  19.1%
White
104
  78.2%
100
  77.5%
204
  77.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.5%
2
   1.6%
4
   1.5%
1.Primary Outcome
Title Mean Sum of Migraine Pain Intensity Differences (SPID)-30
Hide Description SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of "0" indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysis of covariance (ANCOVA) model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The Last Observation Carried Forward (LOCF) imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.
Time Frame Baseline and 30 minutes post-dose (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who experienced at least 1 headache attack per treatment period, received at least 1 dose of study medication (sumatriptan nasal powder or tablet) in each treatment period, and had at least 1 post-Baseline assessment for a treated attack in each treatment period.
Arm/Group Title 20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Hide Arm/Group Description:
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 185 185
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
10.80  (0.880) 7.41  (0.880)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.39
Confidence Interval (2-Sided) 95%
1.76 to 5.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.824
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe
Hide Description SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild and moderate/severe (rated on a 4-point scale: 0=none, 1=mild, 2=moderate, and 3=severe). The range of possible scores for all participants is -60 to +90. For participants with a mild headache at Baseline, the SPID range is -60 to +30. For participants with a moderate/severe headache at Baseline, the SPID range is -30 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of "0" indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The LOCF imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis.
Time Frame Baseline and 30 minutes post-dose (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants with the type of attack specified were analyzed (specified by n=X, X in the corresponding category title). A single participant could have had both a mild and a moderate/severe attack.
Arm/Group Title 20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Hide Arm/Group Description:
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 185 185
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
mild attacks, n=113, 109 3.90  (0.921) 0.24  (0.931)
moderate/severe attacks, n=158, 168 13.83  (1.022) 10.07  (0.997)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.66
Confidence Interval (2-Sided) 95%
1.47 to 5.85
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.105
Estimation Comments mild attacks
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.76
Confidence Interval (2-Sided) 95%
1.84 to 5.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.971
Estimation Comments moderate/severe attacks
3.Secondary Outcome
Title Percentage of Attacks in Which Pain Reduction Was Achieved
Hide Description Percentage of attacks in which pain reduction (defined as a decrease in pain intensity of at least one point on the following scale: 0, none; 1, mild; 2, moderate; 3, severe) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.
Time Frame 10, 15, 30, 45, 60, 90, and 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The LOCF imputation method was used in this analysis.
Arm/Group Title 20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Hide Arm/Group Description:
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 185 185
Overall Number of Units Analyzed
Type of Units Analyzed: Number of attacks
765 766
Measure Type: Number
Unit of Measure: percentage of attacks
10 minutes post-dose 11.5 10.2
15 minutes post-dose 26.4 19.6
30 minutes post-dose 49.0 35.2
45 minutes post-dose 60.7 49.9
60 minutes post-dose 67.2 59.8
90 minutes post-dose 74.6 69.8
120 minutes post-dose 78.0 75.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3549
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.85 to 1.60
Estimation Comments 10 minutes post-dose
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
1.20 to 1.90
Estimation Comments 15 minutes post-dose
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.79
Confidence Interval (2-Sided) 95%
1.45 to 2.21
Estimation Comments 30 minutes post-dose
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
1.24 to 1.96
Estimation Comments 45 minutes post-dose
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0057
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
1.10 to 1.71
Estimation Comments 60 minutes post-dose
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0654
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.99 to 1.61
Estimation Comments 90 minutes post-dose
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2894
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.89 to 1.49
Estimation Comments 120 minutes post-dose
4.Secondary Outcome
Title Percentage of Attacks in Which Pain Freedom Was Achieved
Hide Description Percentage of attacks in which pain freedom (defined as pain level reduced to none [Grade 0]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.
Time Frame Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The LOCF imputation method was used for this analysis.
Arm/Group Title 20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Hide Arm/Group Description:
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 185 185
Overall Number of Units Analyzed
Type of Units Analyzed: Number of attacks
765 766
Measure Type: Number
Unit of Measure: percentage of attacks
10 minutes post-dose 2.5 1.3
15 minutes post-dose 7.2 3.7
30 minutes post-dose 18.2 10.8
45 minutes post-dose 31.0 21.3
60 minutes post-dose 41.2 32.9
90 minutes post-dose 52.8 44.9
120 minutes post-dose 60.4 56.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1771
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.85
Confidence Interval (2-Sided) 95%
0.76 to 4.54
Estimation Comments 10 minutes post-dose
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0077
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.03
Confidence Interval (2-Sided) 95%
1.21 to 3.42
Estimation Comments 15 minutes post-dose
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.82
Confidence Interval (2-Sided) 95%
1.32 to 2.50
Estimation Comments 30 minutes post-dose
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.64
Confidence Interval (2-Sided) 95%
1.29 to 2.09
Estimation Comments 45 minutes post-dose
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.14 to 1.74
Estimation Comments 60 minutes post-dose
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0059
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
1.09 to 1.69
Estimation Comments 90 minutes post-dose
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2717
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.91 to 1.42
Estimation Comments 120 minutes post-dose
5.Secondary Outcome
Title Percentage of Attacks in Which Pain Relief Was Achieved
Hide Description Percentage of attacks treated at a severity of moderate (Grade 2) or severe (Grade 3) in which pain relief (defined as pain level reduced to none [Grade 0] or mild [Grade 1]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.
Time Frame Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The LOCF imputation method was used in this analysis.
Arm/Group Title 20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Hide Arm/Group Description:
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 185 185
Overall Number of Units Analyzed
Type of Units Analyzed: Number of moderate or severe attacks
509 532
Measure Type: Number
Unit of Measure: percentage of attacks
10 minutes post-dose 13.8 11.5
15 minutes post-dose 27.9 20.9
30 minutes post-dose 53.8 38.7
45 minutes post-dose 65.0 53.9
60 minutes post-dose 72.1 62.6
90 minutes post-dose 77.4 72.0
120 minutes post-dose 79.6 76.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2426
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
0.87 to 1.77
Estimation Comments 10 minutes post-dose
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0069
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.49
Confidence Interval (2-Sided) 95%
1.12 to 1.99
Estimation Comments 15 minutes post-dose
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.94
Confidence Interval (2-Sided) 95%
1.47 to 2.56
Estimation Comments 30 minutes post-dose
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.68
Confidence Interval (2-Sided) 95%
1.26 to 2.23
Estimation Comments 45 minutes post-dose
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
1.22 to 2.11
Estimation Comments 60 minutes post-dose
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0272
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.38
Confidence Interval (2-Sided) 95%
1.04 to 1.83
Estimation Comments 90 minutes post-dose
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2085
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.90 to 1.62
Estimation Comments 120 minutes post-dose
6.Secondary Outcome
Title Median Time to Pain Freedom
Hide Description Pain freedom is defined as a pain level reduced to none (Grade 0).
Time Frame 120 minutes post-dose (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. If the participant did not report pain freedom within 120 minutes post-dose, he/she was considered to be censored at the last non-missing result prior to the 120-minute time point.
Arm/Group Title 20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Hide Arm/Group Description:
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 185 185
Median (95% Confidence Interval)
Unit of Measure: minutes
91 [1] 
(NA to NA)
121
(91 to 121)
[1]
The confidence interval is un-estimable due to the number of participants who were observed pain free at the post-dose time points.
7.Secondary Outcome
Title Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
Hide Description Participants were required to record their headache severity score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their headaches on the following severity scale: 0, none; 1, mild; 2, moderate; 3, severe. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.
Arm/Group Title 20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Hide Arm/Group Description:
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 185 185
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
10 minutes post-dose -0.11  (0.018) -0.09  (0.018)
15 minutes post-dose -0.26  (0.029) -0.18  (0.029)
30 minutes post-dose -0.56  (0.042) -0.38  (0.042)
45 minutes post-dose -0.77  (0.049) -0.60  (0.049)
60 minutes post-dose -0.93  (0.051) -0.79  (0.051)
90 minutes post-dose -1.09  (0.052) -0.98  (0.052)
120 minutes post-dose -1.19  (0.053) -1.15  (0.053)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3562
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.06 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.021
Estimation Comments 10 minutes post-dose
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 94%
-0.14 to -0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.029
Estimation Comments 15 minutes post-dose
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.26 to -0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.039
Estimation Comments 30 minutes post-dose
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.26 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.046
Estimation Comments 45 minutes post-dose
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0040
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.24 to -0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.048
Estimation Comments 60 minutes post-dose
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0333
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.21 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.052
Estimation Comments 90 minutes post-dose
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4031
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.15 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.052
Estimation Comments 120 minutes post-dose
8.Secondary Outcome
Title Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
Hide Description Participants were required to record their clinical disability score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.
Arm/Group Title 20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Hide Arm/Group Description:
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 185 185
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
10 minutes post-dose -0.08  (0.017) -0.03  (0.017)
15 minutes post-dose -0.18  (0.025) -0.09  (0.025)
30 minutes post-dose -0.42  (0.038) -0.26  (0.038)
45 minutes post-dose -0.60  (0.046) -0.43  (0.046)
60 minutes post-dose -0.73  (0.049) -0.56  (0.049)
90 minutes post-dose -0.83  (0.052) -0.72  (0.052)
120 minutes post-dose -0.92  (0.054) -0.85  (0.054)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0181
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.08 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.019
Estimation Comments 10 minutes post-dose
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.14 to -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.026
Estimation Comments 15 minutes post-dose
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.23 to -0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.035
Estimation Comments 30 minutes post-dose
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.25 to -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.043
Estimation Comments 45 minutes post-dose
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.26 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.047
Estimation Comments 60 minutes post-dose
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0189
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.21 to -0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.048
Estimation Comments 90 minutes post-dose
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 20 mg Sumatriptan Nasal Powder, 100 mg Sumatriptan Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1704
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.17 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.050
Estimation Comments 120 minutes post-dose
9.Secondary Outcome
Title Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event
Hide Description An adverse event is defined as any untoward medical occurrence associated with the use of an investigational product in humans, whether or not it is considered related to the investigational product. This includes any occurrence that was new in onset or aggravated in severity or frequency from the Baseline condition.
Time Frame Baseline compared to Vist 2, 3 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet
Arm/Group Title 20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Hide Arm/Group Description:
Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 219 228
Measure Type: Number
Unit of Measure: participants
Treatment-emergent Adverse Event 118 73
Treatment-emergent Serious Adverse Event 0 0
10.Secondary Outcome
Title Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
Hide Description Change from Baseline in hemoglobin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 124 110
Mean (Standard Deviation)
Unit of Measure: grams per Liter (g/L)
Visit 3 Number Analyzed 109 participants 95 participants
-1.3  (6.07) -1.3  (6.66)
Visit 4 Number Analyzed 124 participants 110 participants
-2.7  (6.58) -0.8  (6.63)
11.Secondary Outcome
Title Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
Hide Description Change from Baseline in hematocrit (proportion of total blood volume that is composed of red blood cells) was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 124 110
Mean (Standard Deviation)
Unit of Measure: proportion
Visit 3, n=108, 94 -0.002  (0.0204) -0.005  (0.0222)
Visit 4, n=124, 110 -0.005  (0.0222) -0.002  (0.0198)
12.Secondary Outcome
Title Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Hide Description Change from Baseline in red blood cell count was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 124 110
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per Liter
Visit 3, n=109, 95 -0.02  (0.227) -0.04  (0.280)
Visit 4, n=124, 110 -0.05  (0.228) -0.02  (0.209)
13.Secondary Outcome
Title Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Hide Description Change from Baseline in white blood cell (WBC) count, basinophils, monocytes, neutrophils, lymphocytes, eosinophils, and platelets was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 124 110
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per Liter
WBC Count, Visit 3, n=109, 95 -0.10  (1.398) -0.19  (1.381)
WBC Count, Visit 4, n=124, 110 -0.05  (1.477) -0.09  (1.464)
Basophils, Visit 3, n=108, 95 0.000  (0.0301) 0.000  (0.0297)
Basophils, Visit 4, n=124, 110 0.000  (0.0283) -0.001  (0.0235)
Monocytes, Visit 3, n=108, 95 -0.030  (0.1356) -0.022  (0.1160)
Monocytes, Visit 4, n=124, 110 -0.014  (0.1504) -0.026  (0.1281)
Neutrophils, Visit 3, n=108, 95 -0.052  (1.2553) -0.134  (1.1600)
Neutrophils, Visit 4, n=124, 110 -0.059  (1.4270) -0.057  (1.2885)
Lymphocytes, Visit 3, n=108, 95 -0.049  (0.4702) -0.038  (0.3892)
Lymphocytes, Visit 4, n=124, 110 0.012  (0.4252) -0.020  (0.3925)
Eosinophils, Visit 3, n=108, 95 -0.001  (0.0766) 0.006  (0.0493)
Eosinophils, Visit 4, n=124, 110 0.012  (0.1068) 0.013  (0.0824)
Platelets, Visit 3, n=109, 93 -1.9  (29.14) -8.2  (46.92)
Platelets, Visit 4, n=123, 110 -4.0  (27.92) -7.5  (43.40)
14.Secondary Outcome
Title Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Hide Description Change from Baseline in urea was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 123 110
Mean (Standard Deviation)
Unit of Measure: millimoles per Liter (mmol/L)
Visit 3, n=108, 94 0.070  (1.2118) 0.079  (1.2227)
Visit 4, n=123, 110 0.156  (1.2840) 0.308  (1.3674)
15.Secondary Outcome
Title Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Hide Description Change from Baseline in creatinine was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 123 110
Mean (Standard Deviation)
Unit of Measure: micromoles per Liter (µmol/L)
Visit 3, n=108, 94 -1.9  (10.73) -0.7  (6.59)
Visit 4, n=123, 110 -1.3  (11.77) -0.6  (8.24)
16.Secondary Outcome
Title Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Hide Description Change from Baseline in ALP and ALT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 123 110
Mean (Standard Deviation)
Unit of Measure: International Units per Liter (IU/L)
ALP, Visit 3, n=108, 94 -0.5  (8.92) 0.0  (6.78)
ALP, Visit 4, n=123, 110 -1.7  (9.92) -1.0  (9.45)
ALT, Visit 3, n=108, 94 0.4  (7.08) 0.0  (8.86)
ALT, Visit 4, n=123, 110 0.4  (6.83) -0.9  (7.16)
17.Secondary Outcome
Title Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Hide Description Change from Baseline in AST and GGT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 123 110
Mean (Standard Deviation)
Unit of Measure: International Units per Liter (IU/L)
AST, Visit 3, n=108, 92 -0.2  (5.26) 0.5  (14.39)
AST, Visit 4, n=123, 110 0.6  (7.88) -1.2  (5.84)
GGT, Visit 3, n=108, 94 0.8  (10.09) 0.0  (7.05)
GGT, Visit 4, n=123, 110 0.4  (10.31) -0.7  (7.35)
18.Secondary Outcome
Title Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Hide Description Change from Baseline in total bilirubin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 123 110
Mean (Standard Deviation)
Unit of Measure: Units per Liter (U/L)
Visit 3, n=108, 94 0.2  (4.26) -0.2  (2.96)
Visit 4, n=123, 110 -0.6  (4.09) 0.2  (4.01)
19.Secondary Outcome
Title Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Hide Description Change from Baseline in albumin and total protein was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 123 110
Mean (Standard Deviation)
Unit of Measure: grams per Liter (grams/L)
albumin, Visit 3, n=108, 94 -0.8  (2.82) -0.9  (2.84)
albumin, Visit 4, n=123, 110 -0.9  (2.98) -0.5  (2.62)
total protein, Visit 3, n=108, 94 -1.0  (3.75) -1.2  (3.61)
total protein, Visit 4, n=122, 110 -1.2  (4.20) -1.0  (3.35)
20.Secondary Outcome
Title Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Hide Description Change from Baseline in sodium, potassium, chloride, calcium, and glucose was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 123 110
Mean (Standard Deviation)
Unit of Measure: mmoles/L
sodium, Visit 3, n=108, 94 -0.3  (2.62) -0.5  (2.24)
sodium, Visit 4, n=122, 110 -0.3  (2.76) -0.2  (2.25)
potassium, Visit 3, n=108, 94 -0.08  (0.440) -0.04  (0.404)
potassium, Visit 4, n=122, 110 -0.10  (0.411) -0.00  (0.406)
chloride, Visit 3, n=108, 94 -0.1  (2.95) 0.0  (2.39)
chloride, Visit 4, n=122, 110 0.2  (2.62) 0.2  (2.51)
calcium, Visit 3, n=108, 94 -0.019  (0.1017) -0.016  (0.1043)
calcium, Visit 4, n=123, 110 -0.011  (0.1058) -0.006  (0.0886)
glucose, Visit 3, n=108, 94 0.34  (1.316) 0.05  (0.930)
glucose, Visit 4, n=123, 110 0.20  (1.063) 0.24  (1.135)
21.Secondary Outcome
Title Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Hide Description Change from Baseline in urinalysis values was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 124 109
Mean (Standard Deviation)
Unit of Measure: pH
Visit 3, n=108, 95 -0.04  (0.603) -0.03  (0.720)
Visit 4, n=124, 109 0.01  (0.664) -0.07  (0.658)
22.Secondary Outcome
Title Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Hide Description The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Data are based on standard reads, with "1+," "2+," and "3+" indicating increasing amounts of metabolites in urine.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 133 129
Measure Type: Number
Unit of Measure: participants
Protein, Baseline, negative 112 105
Protein, Baseline, trace 16 19
Protein, Baseline, 1+ 5 3
Protein, Baseline, 2+ 0 2
Protein, Visit 3, negative 92 75
Protein, Visit 3, trace 11 15
Protein, Visit 3, 1+ 4 5
Protein, Visit 3, 2+ 1 0
Protein, Visit 4, negative 104 90
Protein, Visit 4, trace 17 12
Protein, Visit 4, 1+ 3 6
Protein, Visit 4, 2+ 0 1
Glucose, Baseline, negative 132 126
Glucose, Baseline, trace 1 2
Glucose, Baseline, 3+ 0 1
Glucose, Visit 3, negative 107 94
Glucose, Visit 3, trace 0 1
Glucose, Visit 3, 3+ 1 0
Glucose, Visit 4, negative 122 108
Glucose, Visit 4, trace 0 1
Glucose, Visit 4, 1+ 1 0
Glucose, Visit 4, 3+ 1 0
Ketones, Baseline, negative 124 121
Ketones, Baseline, trace 7 7
Ketones, Baseline, 1+ 0 1
Ketones, Baseline, 2+ 2 0
Ketones, Visit 3, negative 102 88
Ketones, Visit 3, trace 5 6
Ketones, Visit 3, 1+ 1 0
Ketones, Visit 3, 2+ 0 1
Ketones, Visit 4, negative 119 101
Ketones, Visit 4, trace 3 8
Ketones, Visit 4, 1+ 2 0
Blood, Baseline, negative 116 116
Blood, Baseline, trace 7 4
Blood, Baseline, 1+ 2 3
Blood, Baseline, 2+ 5 1
Blood, Baseline, 3+ 3 5
Blood, Visit 3, negative 94 78
Blood, Visit 3, trace 4 6
Blood, Visit 3, 1+ 5 4
Blood, Visit 3, 2+ 2 2
Blood, Visit 3, 3+ 3 5
Blood, Visit 4, negative 111 94
Blood, Visit 4, trace 3 6
Blood, Visit 4, 1+ 1 5
Blood, Visit 4, 2+ 4 3
Blood, Visit 4, 3+ 5 1
WBCs, Baseline, negative 99 101
WBCs, Baseline, trace 12 8
WBCs, Baseline, 1+ 12 11
WBCs, Baseline, 2+ 7 5
WBCs, Baseline, 3+ 3 4
WBCs, Visit 3, negative 90 75
WBCs, Visit 3, trace 8 7
WBCs, Visit 3, 1+ 4 4
WBCs, Visit 3, 2+ 5 6
WBCs, Visit 3, 3+ 1 3
WBCs, Visit 4, negative 105 85
WBCs, Visit 4, trace 5 7
WBCs, Visit 4, 1+ 4 5
WBCs, Visit 4, 2+ 8 8
WBCs, Visit 4, 3+ 2 4
23.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Hide Description Change from Baseline in SBP and DBP was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 124 111
Mean (Standard Deviation)
Unit of Measure: millimeters of mercury (mmHg)
SBP, Visit 3, n=110, 95 0.1  (11.58) 1.5  (11.46)
SBP, Visit 4, n=124, 111 1.6  (11.52) 2.0  (11.94)
DBP, Visit 3, n=110, 95 -0.2  (7.17) 1.0  (8.89)
DBP, Visit 4, n=124, 111 0.2  (7.42) -0.2  (7.90)
24.Secondary Outcome
Title Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
Hide Description Change from Baseline in pulse was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 124 111
Mean (Standard Deviation)
Unit of Measure: beats per minute
Visit 3, n=110, 95 0.1  (8.63) 0.1  (9.24)
Visit 4, n=124, 111 -2.2  (9.07) -0.2  (10.96)
25.Secondary Outcome
Title Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Hide Description The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). A categorization of "normal" or "abnormal" was made per the investigators' clinical judgment of the ECG, taking the participants' demographic characteristics and other medical conditions into account. CS = clinically significant. CNS = clinically not significant.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 133 129
Measure Type: Number
Unit of Measure: participants
Baseline, normal; n=133, 129 96 99
Baseline, abnormal, CS; n=133, 129 1 0
Baseline, abnormal, CNS; n=133, 129 36 30
Visit 3, normal; n=110, 95 79 70
Visit 3, abnormal, CS; n=110, 95 0 0
Visit 3, abnormal, CNS; n=110, 95 31 25
Visit 4, normal; n=124, 111 90 73
Visit 4, abnormal, CS; n=124, 111 0 1
Visit 4, abnormal, CNS; n=123, 111 34 37
26.Secondary Outcome
Title Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
Hide Description The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). CS = clinically significant. CNS = clinically not significant.
Time Frame Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 133 129
Measure Type: Number
Unit of Measure: participants
Baseline, CS; n=133, 129 1 0
Baseline, CNS; n=133, 129 132 129
Visit 3, CS; n=110, 95 1 2
Visit 3, CNS; n=110, 95 109 93
Visit 4, CS; n=124, 111 0 0
Visit 4, CNS; n=124, 111 124 111
27.Secondary Outcome
Title Number of Participants With the Indicated Concomitant Medications
Hide Description Concomitant medications are defined as non-study medications with a start or stop date between the first dose of study medication and the end of safety follow-up, inclusive. Derm. = dermatologic; incl. - including.
Time Frame up to 24 weeks
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Safety Analysis Set
Arm/Group Title 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)
Hide Arm/Group Description:
In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
Overall Number of Participants Analyzed 219 228
Measure Type: Number
Unit of Measure: participants
Any concomitant medication 218 226
Agents acting on the renin-angiotensin system 12 14
Other therapeutic products 2 2
Allergens 3 4
Anabolic agents for systemic use 1 1
Analgesics 143 148
Anesthetics 6 6
Anti-acne preparations 2 2
Anti-Parkinson drugs 3 3
Antianemic preparations 18 20
Antibacterials for systemic use 13 17
Antibiotics and chemotherapeutics for derm. use 0 2
Antidiarrrheals, intestinal antiinflammatories 7 6
Antiemetics and antinauseants 11 12
Antiepileptics 5 4
Antigout preparations 1 1
Antihistamines for systemic use 38 39
Antiinflammatory and antirheumatic products 135 143
Antimyotics for systemic use 1 3
Antiobesity preparations, exluding diet products 3 3
Antiprotozoals 0 1
Antiseptics and disinfectants 1 0
Antithrombotic agents 8 8
Antivirals for systemic use 2 3
Beta blocking agents 18 15
Calcium channel blockers 9 8
Cardiac therapy 1 1
Corticosteroids for systemic use 7 8
Corticosteroids, dermatologic preparations 1 1
Cough and cold preparations 8 9
Diuretics 6 7
Drugs for acid related disorders 22 23
Drugs for functional gastrointestinal disorders 5 3
Drugs for obstructive airways diseases 20 26
Drugs for treatment of bone diseases 1 1
Drugs used in diabetes 7 9
Ectoparasiticides, incl. scabacides, insecticides 1 0
Gynecological antiinfectives and antiseptics 1 2
Immune sera and immunoglobulins 1 1
Laxatives 4 3
Lipid modifying agents 23 20
Mineral supplements 20 22
Muscle relaxants 12 16
Nasal preparations 25 27
Opthalmologicals 7 6
Other alimentary tract and metabolism products 5 5
Other dermatological preparations 1 1
Other gynecologicals 21 21
Other nervous system drugs 3 3
Otologicals 1 0
Psychoanaleptics 57 60
Psycholeptics 31 31
Sex hormones and modulators of the genital system 62 59
Thyroid therapy 18 16
Unspecified herbal and traditional medicine 11 12
Urologicals 3 4
Vaccines 1 2
Vitamins 57 56
Time Frame Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.
Adverse Event Reporting Description Adverse events were collected in members of the Safety Analysis Set, comprised of all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet.
 
Arm/Group Title 20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Hide Arm/Group Description Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2. Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
All-Cause Mortality
20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/219 (0.00%)   0/228 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
20 mg Sumatriptan Nasal Powder 100 mg Sumatriptan Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   98/219 (44.75%)   35/228 (15.35%) 
Gastrointestinal disorders     
Nausea  1  9/219 (4.11%)  7/228 (3.07%) 
General disorders     
Product taste abnormal  1  57/219 (26.03%)  9/228 (3.95%) 
Infections and infestations     
Ear infection  1  1/219 (0.46%)  3/228 (1.32%) 
Gastroenteritis viral  1  1/219 (0.46%)  3/228 (1.32%) 
Sinusitis  1  3/219 (1.37%)  4/228 (1.75%) 
Upper respiratory tract infection  1  9/219 (4.11%)  8/228 (3.51%) 
Musculoskeletal and connective tissue disorders     
Neck pain  1  1/219 (0.46%)  3/228 (1.32%) 
Nervous system disorders     
Headache  1  2/219 (0.91%)  3/228 (1.32%) 
Respiratory, thoracic and mediastinal disorders     
Nasal discomfort  1  34/219 (15.53%)  3/228 (1.32%) 
Rhinalgia  1  3/219 (1.37%)  0/228 (0.00%) 
Throat irritation  1  4/219 (1.83%)  0/228 (0.00%) 
Upper-airway cough syndrome  1  6/219 (2.74%)  2/228 (0.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Nadine Knowles; Executive Director, Research & Development Operations
Organization: Avanir Pharmaceuticals
Phone: 1-949-268-8972
Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01667679     History of Changes
Other Study ID Numbers: OPN-SUM-MIG-3302
First Submitted: August 6, 2012
First Posted: August 17, 2012
Results First Submitted: October 13, 2016
Results First Posted: March 14, 2017
Last Update Posted: April 12, 2017