A Phase 3 interventional study of 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally and OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet in Migraine and Headaches, sponsored by Avanir Pharmaceuticals. Completed at 13 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-12.
Sponsored by Avanir Pharmaceuticals (part of Otsuka Holdings Co., Ltd.) · Phase 3, Interventional, and Treatment
This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine headaches in 30 minutes after use.
The primary objective for this study is to compare the proportion of attacks in which pain reduction (defined as a decrease in pain intensity of at least 1 point) is achieved at 30 minutes following 20 mg OPTINOSE SUMATRIPTAN treatment with 100 mg Sumatriptan Tablets
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 275 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Avanir Pharmaceuticals is the lead sponsor of 13 studies on the registry; none are open to participants now.
First submitted before Avanir Pharmaceuticals became part of Otsuka Holdings Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20 mg OPTINOSE SUMATRIPTAN Powder Delivered Intranasally With the Bi-directional Device nasally and Placebo Tablet
Drug: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
Drug: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
Mean Sum of Migraine Pain Intensity Differences (SPID)-30
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)
Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe
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)
Percentage of Attacks in Which Pain Reduction Was Achieved
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
Percentage of Attacks in Which Pain Freedom Was Achieved
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)
Percentage of Attacks in Which Pain Relief Was Achieved
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)
Median Time to Pain Freedom
Pain freedom is defined as a pain level reduced to none (Grade 0).
Time frame: 120 minutes post-dose (up to 24 weeks)
Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
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)
Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose
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)
Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event
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
Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
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)
Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)
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)
Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
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)
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)
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)
Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
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)
Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
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)
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)
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)
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)
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)
Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
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)
Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
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)
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
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)
Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
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)
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)
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)
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)
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)
Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)
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)
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)
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)
Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)
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)
Number of Participants With the Indicated Concomitant Medications
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
| Milestone | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| Started | 138 | 137 |
| Completed | 122 | 107 |
| Not completed | 16 | 30 |
| Withdrew: Failure to treat migraine headache | 2 | 6 |
| Withdrew: Dosed incorrectly | 2 | 0 |
| Withdrew: Lack of efficacy | 2 | 0 |
| Withdrew: Could not tolerate diary | 1 | 0 |
| Withdrew: Withdrawal by subject | 6 | 13 |
| Withdrew: Adverse event | 3 | 3 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Non-compliance | 0 | 3 |
| Withdrew: Moved out of state | 0 | 1 |
| Milestone | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| Started | 122 | 107 |
| Completed | 100 | 85 |
| Not completed | 22 | 22 |
| Withdrew: Withdrawal by subject | 6 | 4 |
| Withdrew: Non-compliance with electronic diary | 2 | 0 |
| Withdrew: Lost to follow-up | 8 | 10 |
| Withdrew: Non-compliance | 3 | 4 |
| Withdrew: Sponsor decision | 1 | 0 |
| Withdrew: Failure to treat migraine headache | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Significant improvement in migraine | 0 | 1 |
| Withdrew: Partially dosed | 0 | 1 |
| Withdrew: Brought in before 12 weeks/5 migraines | 0 | 1 |
| Withdrew: Refused last day of visit 4 procedures | 0 | 1 |
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.
| scores on a scale | 20 mg Sumatriptan Nasal Powder | 100 mg Sumatriptan Tablet |
|---|---|---|
| Mean Sum of Migraine Pain Intensity Differences (SPID)-30 | 10.80 ± 0.880 | 7.41 ± 0.880 |
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.
| scores on a scale | 20 mg Sumatriptan Nasal Powder | 100 mg Sumatriptan Tablet |
|---|---|---|
| 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 |
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.
| percentage of attacks | 20 mg Sumatriptan Nasal Powder | 100 mg Sumatriptan Tablet |
|---|---|---|
| 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 |
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.
| percentage of attacks | 20 mg Sumatriptan Nasal Powder | 100 mg Sumatriptan Tablet |
|---|---|---|
| 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 |
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.
| percentage of attacks | 20 mg Sumatriptan Nasal Powder | 100 mg Sumatriptan Tablet |
|---|---|---|
| 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 |
Pain freedom is defined as a pain level reduced to none (Grade 0).
| minutes | 20 mg Sumatriptan Nasal Powder | 100 mg Sumatriptan Tablet |
|---|---|---|
| Median Time to Pain Freedom | 91 (NA to NA) | 121 (91 to 121) |
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.
| scores on a scale | 20 mg Sumatriptan Nasal Powder | 100 mg Sumatriptan Tablet |
|---|---|---|
| 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 |
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.
| scores on a scale | 20 mg Sumatriptan Nasal Powder | 100 mg Sumatriptan Tablet |
|---|---|---|
| 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 |
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.
| participants | 20 mg Sumatriptan Nasal Powder | 100 mg Sumatriptan Tablet |
|---|---|---|
| Treatment-emergent Adverse Event | 118 | 73 |
| Treatment-emergent Serious Adverse Event | 0 | 0 |
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.
| grams per Liter (g/L) | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| Visit 3 | -1.3 ± 6.07 | -1.3 ± 6.66 |
| Visit 4 | -2.7 ± 6.58 | -0.8 ± 6.63 |
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.
| proportion | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| 10^12 cells per Liter | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| 10^9 cells per Liter | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| millimoles per Liter (mmol/L) | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| micromoles per Liter (µmol/L) | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| International Units per Liter (IU/L) | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| International Units per Liter (IU/L) | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| Units per Liter (U/L) | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| grams per Liter (grams/L) | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| mmoles/L | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| pH | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| participants | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| millimeters of mercury (mmHg) | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| beats per minute | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| participants | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| participants | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
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.
| participants | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
|---|---|---|
| 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 |
Collected over Treatment-emergent adverse events were collected from the first dose of investigational product through up to 24 weeks.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 20 mg Sumatriptan Nasal Powder | — | 0/219 (0%) | 98/219 (44.7%) |
| 100 mg Sumatriptan Tablet | — | 0/228 (0%) | 35/228 (15.4%) |
| Event | 20 mg Sumatriptan Nasal Powder | 100 mg Sumatriptan Tablet |
|---|---|---|
| Product taste abnormalGeneral disorders | 57/219 | 9/228 |
| Nasal discomfortRespiratory, thoracic and mediastinal disorders | 34/219 | 3/228 |
| NauseaGastrointestinal disorders | 9/219 | 7/228 |
| Upper respiratory tract infectionInfections and infestations | 9/219 | 8/228 |
| Upper-airway cough syndromeRespiratory, thoracic and mediastinal disorders | 6/219 | 2/228 |
| Throat irritationRespiratory, thoracic and mediastinal disorders | 4/219 | 0/228 |
| SinusitisInfections and infestations | 3/219 | 4/228 |
| RhinalgiaRespiratory, thoracic and mediastinal disorders | 3/219 | 0/228 |
| Ear infectionInfections and infestations | 1/219 | 3/228 |
| Gastroenteritis viralInfections and infestations | 1/219 | 3/228 |
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(Years) | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) | Total |
|---|---|---|---|
| Mean | 39.5 ± 12.55 | 40.7 ± 11.93 | 40.1 ± 12.24 |
| Sex: Female, Male(Participants) | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) | Total |
|---|---|---|---|
| Female | 107 | 115 | 222 |
| Male | 26 | 14 | 40 |
| Race (NIH/OMB)(Participants) | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 24 | 26 | 50 |
| White | 104 | 100 | 204 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 2 | 4 |
The record gives a start of Aug 2012, a primary completion of Mar 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2017, 3 years after primary completion.
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