| Primary | 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. | 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. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | Baseline and 30 minutes post-dose (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan Nasal Powder | Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2. | | OG001 | 100 mg Sumatriptan Tablet | Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00010.80± 0.880
- OG0017.41± 0.880
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | | <0.0001 | | Mean Difference (Final Values) | 3.39 | Standard Error of the Mean | 0.824 | 2-Sided | 95 | 1.76 | 5.01 | | | | | Superiority or Other | | |
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| Secondary | 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. | 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. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | Baseline and 30 minutes post-dose (up to 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 20 mg Sumatriptan Nasal Powder | Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2. |
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| Secondary | 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. | FAS. The LOCF imputation method was used in this analysis. | Posted | | Number | | percentage of attacks | | 10, 15, 30, 45, 60, 90, and 120 minutes | number of attacks | number of attacks | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan Nasal Powder | Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2. | | OG001 | 100 mg Sumatriptan Tablet | Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2. |
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| Secondary | 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. | FAS. The LOCF imputation method was used for this analysis. | Posted | | Number | | percentage of attacks | | Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) | number of attacks | number of attacks | | ID | Title | Description |
|---|
| OG000 | 20 mg Sumatriptan Nasal Powder | Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2. | | OG001 | 100 mg Sumatriptan Tablet | Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2. |
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| Secondary | 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. | FAS. The LOCF imputation method was used in this analysis. | Posted | | Number | | percentage of attacks | | Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) | number of moderate or severe attacks | number of moderate or severe attacks | | ID | Title | Description |
|---|
| OG000 | 20 mg Sumatriptan Nasal Powder | Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2. | | OG001 | 100 mg Sumatriptan Tablet | Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2. |
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| Secondary | Median Time to Pain Freedom | Pain freedom is defined as a pain level reduced to none (Grade 0). | 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. | Posted | | Median | 95% Confidence Interval | minutes | | 120 minutes post-dose (up to 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 20 mg Sumatriptan Nasal Powder | Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2. | | OG001 | 100 mg Sumatriptan Tablet | Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2. |
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| Secondary | 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. | 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. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 20 mg Sumatriptan Nasal Powder | Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2. | | OG001 | 100 mg Sumatriptan Tablet | Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2. |
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| Secondary | 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. | 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. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan Nasal Powder | Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2. | | OG001 | 100 mg Sumatriptan Tablet | Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2. |
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| Secondary | 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. | Safety Analysis Set: all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet | Posted | | Number | | participants | | Baseline compared to Vist 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan Nasal Powder | Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2. | | OG001 | 100 mg Sumatriptan Tablet | Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2. |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | grams per Liter (g/L) | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | proportion | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | 10^12 cells per Liter | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | 10^9 cells per Liter | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | millimoles per Liter (mmol/L) | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | micromoles per Liter (µmol/L) | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | International Units per Liter (IU/L) | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | International Units per Liter (IU/L) | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | Units per Liter (U/L) | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | grams per Liter (grams/L) | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | mmoles/L | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | pH | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
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| Secondary | 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. | | Posted | | Number | | participants | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) | 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. |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | millimeters of mercury (mmHg) | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 |
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| Secondary | 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. | 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). | Posted | | Mean | Standard Deviation | beats per minute | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
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| Secondary | 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. | | Posted | | Number | | participants | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) |
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| Secondary | 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. | | Posted | | Number | | participants | | Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks) | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) | 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. |
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| Secondary | 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. | | Posted | | Number | | participants | | up to 24 weeks | | | | ID | Title | Description |
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| OG000 | 20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2) | 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. | | OG001 | 100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2) | 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. |
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