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

A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Cross-Over Study Evaluating the Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01667679

Acronym

COMPASS

Enrollment

275

Registered

2012-08-17

Start date

2012-08-31

Completion date

2014-06-30

Last updated

2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headaches, Migraine

Keywords

Migraine, Headaches, Sumatriptan

Brief summary

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.

Detailed description

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

Interventions

DRUG100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally

DRUGOPTINOSE SUMATRIPTAN delivered nasally and placebo tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Man or woman, between the ages of 18 to 65 years, inclusive at screening * Have a diagnosis of episodic migraine, with or without aura according to InternationalClassification of Headache Disorders (2nd Edition) (ICHD-2) for at least 1 year prior to screening * Experiences between 2 and 8 migraine attacks per month for the past 12 months * Women of child bearing potential must be practicing an effective method of birth control * Women of child-bearing potential must have a negative urine pregnancy test at the screening visit and a negative urine pregnancy test at the randomization visit * Demonstrate the ability to use the bi-directional delivery device correctly * Able and willing to read and comprehend written instructions and complete the electronic diary information required by the protocol * Must be capable, in the opinion of the Investigator, of providing informed consent to participate in the study. Subjects (and their legally acceptable representatives, if applicable) must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion criteria

* Inability to distinguish other headaches from migraine * Experiences headache of any kind at a frequency greater than or equal to 15 days per month * History of resistance to sumatriptan, or non-response to 2 or more other triptans, defined as subjects who have not responded to an adequate dose and duration of treatment * Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening * Chronic opioid therapy (\>3 consecutive days in the 30 days prior to screening) * Current treatment with monoamine oxidase A (MAO-A) inhibitors or use within 4 weeks before randomization * Have hemiplegic or basilar migraine * History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort, vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease, Raynaud syndrome * Uncontrolled hypertension (screening systolic/diastolic blood pressure \>140/95 mmHg) * Have severe hepatic impairment * Have history of epilepsy or conditions associated with a lowered seizure threshold * History (within 2 years) of drug or alcohol abuse as defined by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria

Design outcomes

Primary

Measure	Time frame	Description
Mean Sum of Migraine Pain Intensity Differences (SPID)-30	Baseline and 30 minutes post-dose (up to 24 weeks)	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.

Secondary

Measure	Time frame	Description
Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe	Baseline and 30 minutes post-dose (up to 24 weeks)	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.
Percentage of Attacks in Which Pain Reduction Was Achieved	10, 15, 30, 45, 60, 90, and 120 minutes	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 in Which Pain Relief Was Achieved	Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)	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.
Median Time to Pain Freedom	120 minutes post-dose (up to 24 weeks)	Pain freedom is defined as a pain level reduced to none (Grade 0).
Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)	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.
Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)	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.
Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event	Baseline compared to Vist 2, 3 and 4	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.
Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)	Baseline and Visits 3 (up to 12 weeks) and 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.
Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)	Baseline and Visits 3 (up to 12 weeks) and 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.
Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
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)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
Percentage of Attacks in Which Pain Freedom Was Achieved	Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)	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.
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)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
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)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
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)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
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)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
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)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.
Number of Participants With the Indicated Concomitant Medications	up to 24 weeks	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.
Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)	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.

Countries

United States

Participant flow

Pre-assignment details

A total of 334 participants were assessed for eligibility; of these, 275 participants were randomized.

Participants by arm

Arm	Count
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, 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.	133
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, 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.	129
Total	262

Withdrawals & dropouts

Period	Reason	FG000	FG001
Treatment Period 1 (<=12 Weeks)	Adverse Event	3	3
Treatment Period 1 (<=12 Weeks)	Could Not Tolerate Diary	1	0
Treatment Period 1 (<=12 Weeks)	Dosed Incorrectly	2	0
Treatment Period 1 (<=12 Weeks)	Failure to Treat Migraine Headache	2	6
Treatment Period 1 (<=12 Weeks)	Lack of Efficacy	2	0
Treatment Period 1 (<=12 Weeks)	Lost to Follow-up	0	2
Treatment Period 1 (<=12 Weeks)	Moved Out of State	0	1
Treatment Period 1 (<=12 Weeks)	Non-compliance	0	3
Treatment Period 1 (<=12 Weeks)	Protocol Violation	0	2
Treatment Period 1 (<=12 Weeks)	Withdrawal by Subject	6	13
Treatment Period 2 (<=12 Weeks)	Adverse Event	1	0
Treatment Period 2 (<=12 Weeks)	Brought in before 12 Weeks/5 Migraines	0	1
Treatment Period 2 (<=12 Weeks)	Failure to Treat Migraine Headache	1	0
Treatment Period 2 (<=12 Weeks)	Lost to Follow-up	8	10
Treatment Period 2 (<=12 Weeks)	Non-compliance	3	4
Treatment Period 2 (<=12 Weeks)	Non-compliance with Electronic Diary	2	0
Treatment Period 2 (<=12 Weeks)	Partially Dosed	0	1
Treatment Period 2 (<=12 Weeks)	Refused Last Day of Visit 4 Procedures	0	1
Treatment Period 2 (<=12 Weeks)	Significant Improvement in Migraine	0	1
Treatment Period 2 (<=12 Weeks)	Sponsor Decision	1	0
Treatment Period 2 (<=12 Weeks)	Withdrawal by Subject	6	4

Baseline characteristics

Characteristic	100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)	Total	20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)
Age, Continuous	40.7 Years STANDARD_DEVIATION 11.93	40.1 Years STANDARD_DEVIATION 12.24	39.5 Years STANDARD_DEVIATION 12.55
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	4 Participants	3 Participants
Race (NIH/OMB) Black or African American	26 Participants	50 Participants	24 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	4 Participants	2 Participants
Race (NIH/OMB) White	100 Participants	204 Participants	104 Participants
Sex: Female, Male Female	115 Participants	222 Participants	107 Participants
Sex: Female, Male Male	14 Participants	40 Participants	26 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	98 / 219	35 / 228
serious Total, serious adverse events	0 / 219	0 / 228

Outcome results

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.

Time frame: Baseline and 30 minutes post-dose (up to 24 weeks)

Population: Full Analysis Set (FAS): all participants who experienced at least 1 headache attack per treatment period, received at least 1 dose of study medication (sumatriptan nasal powder or tablet) in each treatment period, and had at least 1 post-Baseline assessment for a treated attack in each treatment period.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Mean Sum of Migraine Pain Intensity Differences (SPID)-30	10.80 scores on a scale	Standard Error 0.88
100 mg Sumatriptan Tablet	Mean Sum of Migraine Pain Intensity Differences (SPID)-30	7.41 scores on a scale	Standard Error 0.88

p-value: <0.000195% CI: [1.76, 5.01]ANCOVA

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	albumin, Visit 3, n=108, 94	-0.8 grams per Liter (grams/L)	Standard Deviation 2.82
20 mg Sumatriptan Nasal Powder	Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	albumin, Visit 4, n=123, 110	-0.9 grams per Liter (grams/L)	Standard Deviation 2.98
20 mg Sumatriptan Nasal Powder	Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	total protein, Visit 3, n=108, 94	-1.0 grams per Liter (grams/L)	Standard Deviation 3.75
20 mg Sumatriptan Nasal Powder	Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	total protein, Visit 4, n=122, 110	-1.2 grams per Liter (grams/L)	Standard Deviation 4.2
100 mg Sumatriptan Tablet	Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	total protein, Visit 4, n=122, 110	-1.0 grams per Liter (grams/L)	Standard Deviation 3.35
100 mg Sumatriptan Tablet	Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	albumin, Visit 3, n=108, 94	-0.9 grams per Liter (grams/L)	Standard Deviation 2.84
100 mg Sumatriptan Tablet	Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	total protein, Visit 3, n=108, 94	-1.2 grams per Liter (grams/L)	Standard Deviation 3.61
100 mg Sumatriptan Tablet	Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	albumin, Visit 4, n=123, 110	-0.5 grams per Liter (grams/L)	Standard Deviation 2.62

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	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)	ALP, Visit 3, n=108, 94	-0.5 International Units per Liter (IU/L)	Standard Deviation 8.92
20 mg Sumatriptan Nasal Powder	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)	ALP, Visit 4, n=123, 110	-1.7 International Units per Liter (IU/L)	Standard Deviation 9.92
20 mg Sumatriptan Nasal Powder	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)	ALT, Visit 3, n=108, 94	0.4 International Units per Liter (IU/L)	Standard Deviation 7.08
20 mg Sumatriptan Nasal Powder	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)	ALT, Visit 4, n=123, 110	0.4 International Units per Liter (IU/L)	Standard Deviation 6.83
100 mg Sumatriptan Tablet	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)	ALT, Visit 4, n=123, 110	-0.9 International Units per Liter (IU/L)	Standard Deviation 7.16
100 mg Sumatriptan Tablet	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)	ALP, Visit 3, n=108, 94	0.0 International Units per Liter (IU/L)	Standard Deviation 6.78
100 mg Sumatriptan Tablet	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)	ALT, Visit 3, n=108, 94	0.0 International Units per Liter (IU/L)	Standard Deviation 8.86
100 mg Sumatriptan Tablet	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)	ALP, Visit 4, n=123, 110	-1.0 International Units per Liter (IU/L)	Standard Deviation 9.45

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	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)	AST, Visit 3, n=108, 92	-0.2 International Units per Liter (IU/L)	Standard Deviation 5.26
20 mg Sumatriptan Nasal Powder	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)	AST, Visit 4, n=123, 110	0.6 International Units per Liter (IU/L)	Standard Deviation 7.88
20 mg Sumatriptan Nasal Powder	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)	GGT, Visit 3, n=108, 94	0.8 International Units per Liter (IU/L)	Standard Deviation 10.09
20 mg Sumatriptan Nasal Powder	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)	GGT, Visit 4, n=123, 110	0.4 International Units per Liter (IU/L)	Standard Deviation 10.31
100 mg Sumatriptan Tablet	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)	GGT, Visit 4, n=123, 110	-0.7 International Units per Liter (IU/L)	Standard Deviation 7.35
100 mg Sumatriptan Tablet	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)	AST, Visit 3, n=108, 92	0.5 International Units per Liter (IU/L)	Standard Deviation 14.39
100 mg Sumatriptan Tablet	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)	GGT, Visit 3, n=108, 94	0.0 International Units per Liter (IU/L)	Standard Deviation 7.05
100 mg Sumatriptan Tablet	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)	AST, Visit 4, n=123, 110	-1.2 International Units per Liter (IU/L)	Standard Deviation 5.84

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 3, n=108, 94	-1.9 micromoles per Liter (µmol/L)	Standard Deviation 10.73
20 mg Sumatriptan Nasal Powder	Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 4, n=123, 110	-1.3 micromoles per Liter (µmol/L)	Standard Deviation 11.77
100 mg Sumatriptan Tablet	Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 3, n=108, 94	-0.7 micromoles per Liter (µmol/L)	Standard Deviation 6.59
100 mg Sumatriptan Tablet	Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 4, n=123, 110	-0.6 micromoles per Liter (µmol/L)	Standard Deviation 8.24

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)	Visit 3, n=108, 94	-0.002 proportion	Standard Deviation 0.0204
20 mg Sumatriptan Nasal Powder	Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)	Visit 4, n=124, 110	-0.005 proportion	Standard Deviation 0.0222
100 mg Sumatriptan Tablet	Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)	Visit 3, n=108, 94	-0.005 proportion	Standard Deviation 0.0222
100 mg Sumatriptan Tablet	Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)	Visit 4, n=124, 110	-0.002 proportion	Standard Deviation 0.0198

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)	Visit 3	-1.3 grams per Liter (g/L)	Standard Deviation 6.07
20 mg Sumatriptan Nasal Powder	Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)	Visit 4	-2.7 grams per Liter (g/L)	Standard Deviation 6.58
100 mg Sumatriptan Tablet	Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)	Visit 3	-1.3 grams per Liter (g/L)	Standard Deviation 6.66
100 mg Sumatriptan Tablet	Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)	Visit 4	-0.8 grams per Liter (g/L)	Standard Deviation 6.63

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 3, n=110, 95	0.1 beats per minute	Standard Deviation 8.63
20 mg Sumatriptan Nasal Powder	Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 4, n=124, 111	-2.2 beats per minute	Standard Deviation 9.07
100 mg Sumatriptan Tablet	Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 3, n=110, 95	0.1 beats per minute	Standard Deviation 9.24
100 mg Sumatriptan Tablet	Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 4, n=124, 111	-0.2 beats per minute	Standard Deviation 10.96

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 3, n=109, 95	-0.02 10^12 cells per Liter	Standard Deviation 0.227
20 mg Sumatriptan Nasal Powder	Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 4, n=124, 110	-0.05 10^12 cells per Liter	Standard Deviation 0.228
100 mg Sumatriptan Tablet	Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 3, n=109, 95	-0.04 10^12 cells per Liter	Standard Deviation 0.28
100 mg Sumatriptan Tablet	Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 4, n=124, 110	-0.02 10^12 cells per Liter	Standard Deviation 0.209

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	sodium, Visit 3, n=108, 94	-0.3 mmoles/L	Standard Deviation 2.62
20 mg Sumatriptan Nasal Powder	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	sodium, Visit 4, n=122, 110	-0.3 mmoles/L	Standard Deviation 2.76
20 mg Sumatriptan Nasal Powder	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	potassium, Visit 3, n=108, 94	-0.08 mmoles/L	Standard Deviation 0.44
20 mg Sumatriptan Nasal Powder	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	potassium, Visit 4, n=122, 110	-0.10 mmoles/L	Standard Deviation 0.411
20 mg Sumatriptan Nasal Powder	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	chloride, Visit 3, n=108, 94	-0.1 mmoles/L	Standard Deviation 2.95
20 mg Sumatriptan Nasal Powder	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	chloride, Visit 4, n=122, 110	0.2 mmoles/L	Standard Deviation 2.62
20 mg Sumatriptan Nasal Powder	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	calcium, Visit 3, n=108, 94	-0.019 mmoles/L	Standard Deviation 0.1017
20 mg Sumatriptan Nasal Powder	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	calcium, Visit 4, n=123, 110	-0.011 mmoles/L	Standard Deviation 0.1058
20 mg Sumatriptan Nasal Powder	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	glucose, Visit 3, n=108, 94	0.34 mmoles/L	Standard Deviation 1.316
20 mg Sumatriptan Nasal Powder	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	glucose, Visit 4, n=123, 110	0.20 mmoles/L	Standard Deviation 1.063
100 mg Sumatriptan Tablet	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	calcium, Visit 4, n=123, 110	-0.006 mmoles/L	Standard Deviation 0.0886
100 mg Sumatriptan Tablet	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	sodium, Visit 3, n=108, 94	-0.5 mmoles/L	Standard Deviation 2.24
100 mg Sumatriptan Tablet	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	chloride, Visit 4, n=122, 110	0.2 mmoles/L	Standard Deviation 2.51
100 mg Sumatriptan Tablet	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	sodium, Visit 4, n=122, 110	-0.2 mmoles/L	Standard Deviation 2.25
100 mg Sumatriptan Tablet	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	glucose, Visit 4, n=123, 110	0.24 mmoles/L	Standard Deviation 1.135
100 mg Sumatriptan Tablet	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	potassium, Visit 3, n=108, 94	-0.04 mmoles/L	Standard Deviation 0.404
100 mg Sumatriptan Tablet	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	calcium, Visit 3, n=108, 94	-0.016 mmoles/L	Standard Deviation 0.1043
100 mg Sumatriptan Tablet	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	potassium, Visit 4, n=122, 110	-0.00 mmoles/L	Standard Deviation 0.406
100 mg Sumatriptan Tablet	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	glucose, Visit 3, n=108, 94	0.05 mmoles/L	Standard Deviation 0.93
100 mg Sumatriptan Tablet	Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	chloride, Visit 3, n=108, 94	0.0 mmoles/L	Standard Deviation 2.39

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	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)	SBP, Visit 3, n=110, 95	0.1 millimeters of mercury (mmHg)	Standard Deviation 11.58
20 mg Sumatriptan Nasal Powder	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)	SBP, Visit 4, n=124, 111	1.6 millimeters of mercury (mmHg)	Standard Deviation 11.52
20 mg Sumatriptan Nasal Powder	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)	DBP, Visit 3, n=110, 95	-0.2 millimeters of mercury (mmHg)	Standard Deviation 7.17
20 mg Sumatriptan Nasal Powder	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)	DBP, Visit 4, n=124, 111	0.2 millimeters of mercury (mmHg)	Standard Deviation 7.42
100 mg Sumatriptan Tablet	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)	DBP, Visit 4, n=124, 111	-0.2 millimeters of mercury (mmHg)	Standard Deviation 7.9
100 mg Sumatriptan Tablet	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)	SBP, Visit 3, n=110, 95	1.5 millimeters of mercury (mmHg)	Standard Deviation 11.46
100 mg Sumatriptan Tablet	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)	DBP, Visit 3, n=110, 95	1.0 millimeters of mercury (mmHg)	Standard Deviation 8.89
100 mg Sumatriptan Tablet	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)	SBP, Visit 4, n=124, 111	2.0 millimeters of mercury (mmHg)	Standard Deviation 11.94

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 3, n=108, 94	0.2 Units per Liter (U/L)	Standard Deviation 4.26
20 mg Sumatriptan Nasal Powder	Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 4, n=123, 110	-0.6 Units per Liter (U/L)	Standard Deviation 4.09
100 mg Sumatriptan Tablet	Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 3, n=108, 94	-0.2 Units per Liter (U/L)	Standard Deviation 2.96
100 mg Sumatriptan Tablet	Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 4, n=123, 110	0.2 Units per Liter (U/L)	Standard Deviation 4.01

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 3, n=108, 94	0.070 millimoles per Liter (mmol/L)	Standard Deviation 1.2118
20 mg Sumatriptan Nasal Powder	Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 4, n=123, 110	0.156 millimoles per Liter (mmol/L)	Standard Deviation 1.284
100 mg Sumatriptan Tablet	Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 3, n=108, 94	0.079 millimoles per Liter (mmol/L)	Standard Deviation 1.2227
100 mg Sumatriptan Tablet	Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 4, n=123, 110	0.308 millimoles per Liter (mmol/L)	Standard Deviation 1.3674

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 3, n=108, 95	-0.04 pH	Standard Deviation 0.603
20 mg Sumatriptan Nasal Powder	Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 4, n=124, 109	0.01 pH	Standard Deviation 0.664
100 mg Sumatriptan Tablet	Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 3, n=108, 95	-0.03 pH	Standard Deviation 0.72
100 mg Sumatriptan Tablet	Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)	Visit 4, n=124, 109	-0.07 pH	Standard Deviation 0.658

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	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)	WBC Count, Visit 3, n=109, 95	-0.10 10^9 cells per Liter	Standard Deviation 1.398
20 mg Sumatriptan Nasal Powder	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)	WBC Count, Visit 4, n=124, 110	-0.05 10^9 cells per Liter	Standard Deviation 1.477
20 mg Sumatriptan Nasal Powder	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)	Basophils, Visit 3, n=108, 95	0.000 10^9 cells per Liter	Standard Deviation 0.0301
20 mg Sumatriptan Nasal Powder	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)	Basophils, Visit 4, n=124, 110	0.000 10^9 cells per Liter	Standard Deviation 0.0283
20 mg Sumatriptan Nasal Powder	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)	Monocytes, Visit 3, n=108, 95	-0.030 10^9 cells per Liter	Standard Deviation 0.1356
20 mg Sumatriptan Nasal Powder	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)	Monocytes, Visit 4, n=124, 110	-0.014 10^9 cells per Liter	Standard Deviation 0.1504
20 mg Sumatriptan Nasal Powder	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)	Neutrophils, Visit 3, n=108, 95	-0.052 10^9 cells per Liter	Standard Deviation 1.2553
20 mg Sumatriptan Nasal Powder	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)	Neutrophils, Visit 4, n=124, 110	-0.059 10^9 cells per Liter	Standard Deviation 1.427
20 mg Sumatriptan Nasal Powder	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)	Lymphocytes, Visit 3, n=108, 95	-0.049 10^9 cells per Liter	Standard Deviation 0.4702
20 mg Sumatriptan Nasal Powder	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)	Lymphocytes, Visit 4, n=124, 110	0.012 10^9 cells per Liter	Standard Deviation 0.4252
20 mg Sumatriptan Nasal Powder	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)	Eosinophils, Visit 3, n=108, 95	-0.001 10^9 cells per Liter	Standard Deviation 0.0766
20 mg Sumatriptan Nasal Powder	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)	Eosinophils, Visit 4, n=124, 110	0.012 10^9 cells per Liter	Standard Deviation 0.1068
20 mg Sumatriptan Nasal Powder	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)	Platelets, Visit 3, n=109, 93	-1.9 10^9 cells per Liter	Standard Deviation 29.14
20 mg Sumatriptan Nasal Powder	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)	Platelets, Visit 4, n=123, 110	-4.0 10^9 cells per Liter	Standard Deviation 27.92
100 mg Sumatriptan Tablet	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)	Eosinophils, Visit 3, n=108, 95	0.006 10^9 cells per Liter	Standard Deviation 0.0493
100 mg Sumatriptan Tablet	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)	WBC Count, Visit 3, n=109, 95	-0.19 10^9 cells per Liter	Standard Deviation 1.381
100 mg Sumatriptan Tablet	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)	Neutrophils, Visit 4, n=124, 110	-0.057 10^9 cells per Liter	Standard Deviation 1.2885
100 mg Sumatriptan Tablet	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)	WBC Count, Visit 4, n=124, 110	-0.09 10^9 cells per Liter	Standard Deviation 1.464
100 mg Sumatriptan Tablet	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)	Platelets, Visit 3, n=109, 93	-8.2 10^9 cells per Liter	Standard Deviation 46.92
100 mg Sumatriptan Tablet	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)	Basophils, Visit 3, n=108, 95	0.000 10^9 cells per Liter	Standard Deviation 0.0297
100 mg Sumatriptan Tablet	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)	Lymphocytes, Visit 3, n=108, 95	-0.038 10^9 cells per Liter	Standard Deviation 0.3892
100 mg Sumatriptan Tablet	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)	Basophils, Visit 4, n=124, 110	-0.001 10^9 cells per Liter	Standard Deviation 0.0235
100 mg Sumatriptan Tablet	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)	Eosinophils, Visit 4, n=124, 110	0.013 10^9 cells per Liter	Standard Deviation 0.0824
100 mg Sumatriptan Tablet	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)	Monocytes, Visit 3, n=108, 95	-0.022 10^9 cells per Liter	Standard Deviation 0.116
100 mg Sumatriptan Tablet	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)	Lymphocytes, Visit 4, n=124, 110	-0.020 10^9 cells per Liter	Standard Deviation 0.3925
100 mg Sumatriptan Tablet	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)	Monocytes, Visit 4, n=124, 110	-0.026 10^9 cells per Liter	Standard Deviation 0.1281
100 mg Sumatriptan Tablet	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)	Platelets, Visit 4, n=123, 110	-7.5 10^9 cells per Liter	Standard Deviation 43.4
100 mg Sumatriptan Tablet	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)	Neutrophils, Visit 3, n=108, 95	-0.134 10^9 cells per Liter	Standard Deviation 1.16

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.

Time frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)

Population: FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	30 minutes post-dose	-0.42 scores on a scale	Standard Error 0.038
20 mg Sumatriptan Nasal Powder	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	60 minutes post-dose	-0.73 scores on a scale	Standard Error 0.049
20 mg Sumatriptan Nasal Powder	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	15 minutes post-dose	-0.18 scores on a scale	Standard Error 0.025
20 mg Sumatriptan Nasal Powder	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	90 minutes post-dose	-0.83 scores on a scale	Standard Error 0.052
20 mg Sumatriptan Nasal Powder	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	45 minutes post-dose	-0.60 scores on a scale	Standard Error 0.046
20 mg Sumatriptan Nasal Powder	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	120 minutes post-dose	-0.92 scores on a scale	Standard Error 0.054
20 mg Sumatriptan Nasal Powder	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	10 minutes post-dose	-0.08 scores on a scale	Standard Error 0.017
100 mg Sumatriptan Tablet	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	120 minutes post-dose	-0.85 scores on a scale	Standard Error 0.054
100 mg Sumatriptan Tablet	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	10 minutes post-dose	-0.03 scores on a scale	Standard Error 0.017
100 mg Sumatriptan Tablet	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	15 minutes post-dose	-0.09 scores on a scale	Standard Error 0.025
100 mg Sumatriptan Tablet	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	30 minutes post-dose	-0.26 scores on a scale	Standard Error 0.038
100 mg Sumatriptan Tablet	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	45 minutes post-dose	-0.43 scores on a scale	Standard Error 0.046
100 mg Sumatriptan Tablet	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	60 minutes post-dose	-0.56 scores on a scale	Standard Error 0.049
100 mg Sumatriptan Tablet	Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	90 minutes post-dose	-0.72 scores on a scale	Standard Error 0.052

p-value: 0.018195% CI: [-0.08, -0.01]ANCOVA

p-value: 0.000395% CI: [-0.14, -0.04]ANCOVA

p-value: <0.000195% CI: [-0.23, -0.09]ANCOVA

p-value: 0.000195% CI: [-0.25, -0.08]ANCOVA

p-value: 0.000695% CI: [-0.26, -0.07]ANCOVA

p-value: 0.018995% CI: [-0.21, -0.02]ANCOVA

p-value: 0.170495% CI: [-0.17, 0.03]ANCOVA

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.

Time frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	30 minutes post-dose	-0.56 scores on a scale	Standard Error 0.042
20 mg Sumatriptan Nasal Powder	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	60 minutes post-dose	-0.93 scores on a scale	Standard Error 0.051
20 mg Sumatriptan Nasal Powder	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	15 minutes post-dose	-0.26 scores on a scale	Standard Error 0.029
20 mg Sumatriptan Nasal Powder	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	90 minutes post-dose	-1.09 scores on a scale	Standard Error 0.052
20 mg Sumatriptan Nasal Powder	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	45 minutes post-dose	-0.77 scores on a scale	Standard Error 0.049
20 mg Sumatriptan Nasal Powder	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	120 minutes post-dose	-1.19 scores on a scale	Standard Error 0.053
20 mg Sumatriptan Nasal Powder	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	10 minutes post-dose	-0.11 scores on a scale	Standard Error 0.018
100 mg Sumatriptan Tablet	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	120 minutes post-dose	-1.15 scores on a scale	Standard Error 0.053
100 mg Sumatriptan Tablet	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	10 minutes post-dose	-0.09 scores on a scale	Standard Error 0.018
100 mg Sumatriptan Tablet	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	15 minutes post-dose	-0.18 scores on a scale	Standard Error 0.029
100 mg Sumatriptan Tablet	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	30 minutes post-dose	-0.38 scores on a scale	Standard Error 0.042
100 mg Sumatriptan Tablet	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	45 minutes post-dose	-0.60 scores on a scale	Standard Error 0.049
100 mg Sumatriptan Tablet	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	60 minutes post-dose	-0.79 scores on a scale	Standard Error 0.051
100 mg Sumatriptan Tablet	Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose	90 minutes post-dose	-0.98 scores on a scale	Standard Error 0.052

p-value: 0.356295% CI: [-0.06, 0.02]ANCOVA

p-value: 0.006394% CI: [-0.14, -0.02]ANCOVA

p-value: <0.000195% CI: [-0.26, -0.11]ANCOVA

p-value: 0.000595% CI: [-0.26, -0.07]ANCOVA

p-value: 0.00495% CI: [-0.24, -0.05]ANCOVA

p-value: 0.033395% CI: [-0.21, -0.01]ANCOVA

p-value: 0.403195% CI: [-0.15, 0.06]ANCOVA

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.

Time frame: Baseline and 30 minutes post-dose (up to 24 weeks)

Population: FAS. Only those participants with the type of attack specified were analyzed (specified by n=X, X in the corresponding category title). A single participant could have had both a mild and a moderate/severe attack.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
20 mg Sumatriptan Nasal Powder	Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe	mild attacks, n=113, 109	3.90 scores on a scale	Standard Error 0.921
20 mg Sumatriptan Nasal Powder	Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe	moderate/severe attacks, n=158, 168	13.83 scores on a scale	Standard Error 1.022
100 mg Sumatriptan Tablet	Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe	mild attacks, n=113, 109	0.24 scores on a scale	Standard Error 0.931
100 mg Sumatriptan Tablet	Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe	moderate/severe attacks, n=158, 168	10.07 scores on a scale	Standard Error 0.997

p-value: 0.001395% CI: [1.47, 5.85]ANCOVA

p-value: 0.000295% CI: [1.84, 5.68]ANCOVA

Secondary

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)

Population: FAS. If the participant did not report pain freedom within 120 minutes post-dose, he/she was considered to be censored at the last non-missing result prior to the 120-minute time point.

Arm	Measure	Value (MEDIAN)
20 mg Sumatriptan Nasal Powder	Median Time to Pain Freedom	91 minutes
100 mg Sumatriptan Tablet	Median Time to Pain Freedom	121 minutes

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.

Time frame: Baseline compared to Vist 2, 3 and 4

Population: Safety Analysis Set: all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet

Arm	Measure	Group	Value (NUMBER)
20 mg Sumatriptan Nasal Powder	Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event	Treatment-emergent Adverse Event	118 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event	Treatment-emergent Serious Adverse Event	0 participants
100 mg Sumatriptan Tablet	Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event	Treatment-emergent Adverse Event	73 participants
100 mg Sumatriptan Tablet	Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event	Treatment-emergent Serious Adverse Event	0 participants

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set

Arm	Measure	Group	Value (NUMBER)
20 mg Sumatriptan Nasal Powder	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)	Baseline, abnormal, CS; n=133, 129	1 participants
20 mg Sumatriptan Nasal Powder	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)	Visit 3, abnormal, CNS; n=110, 95	31 participants
20 mg Sumatriptan Nasal Powder	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)	Visit 3, normal; n=110, 95	79 participants
20 mg Sumatriptan Nasal Powder	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)	Visit 4, normal; n=124, 111	90 participants
20 mg Sumatriptan Nasal Powder	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)	Baseline, abnormal, CNS; n=133, 129	36 participants
20 mg Sumatriptan Nasal Powder	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)	Visit 4, abnormal, CS; n=124, 111	0 participants
20 mg Sumatriptan Nasal Powder	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)	Visit 3, abnormal, CS; n=110, 95	0 participants
20 mg Sumatriptan Nasal Powder	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)	Visit 4, abnormal, CNS; n=123, 111	34 participants
20 mg Sumatriptan Nasal Powder	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)	Baseline, normal; n=133, 129	96 participants
100 mg Sumatriptan Tablet	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)	Visit 4, abnormal, CNS; n=123, 111	37 participants
100 mg Sumatriptan Tablet	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)	Baseline, normal; n=133, 129	99 participants
100 mg Sumatriptan Tablet	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)	Baseline, abnormal, CS; n=133, 129	0 participants
100 mg Sumatriptan Tablet	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)	Baseline, abnormal, CNS; n=133, 129	30 participants
100 mg Sumatriptan Tablet	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)	Visit 3, normal; n=110, 95	70 participants
100 mg Sumatriptan Tablet	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)	Visit 3, abnormal, CS; n=110, 95	0 participants
100 mg Sumatriptan Tablet	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)	Visit 3, abnormal, CNS; n=110, 95	25 participants
100 mg Sumatriptan Tablet	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)	Visit 4, normal; n=124, 111	73 participants
100 mg Sumatriptan Tablet	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)	Visit 4, abnormal, CS; n=124, 111	1 participants

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.

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set

Arm	Measure	Group	Value (NUMBER)
20 mg Sumatriptan Nasal Powder	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)	Protein, Baseline, negative	112 participants
20 mg Sumatriptan Nasal Powder	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)	Protein, Baseline, trace	16 participants
20 mg Sumatriptan Nasal Powder	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)	Protein, Baseline, 1+	5 participants
20 mg Sumatriptan Nasal Powder	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)	Protein, Baseline, 2+	0 participants
20 mg Sumatriptan Nasal Powder	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)	Protein, Visit 3, negative	92 participants
20 mg Sumatriptan Nasal Powder	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)	Protein, Visit 3, trace	11 participants
20 mg Sumatriptan Nasal Powder	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)	Protein, Visit 3, 1+	4 participants
20 mg Sumatriptan Nasal Powder	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)	Protein, Visit 3, 2+	1 participants
20 mg Sumatriptan Nasal Powder	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)	Protein, Visit 4, negative	104 participants
20 mg Sumatriptan Nasal Powder	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)	Protein, Visit 4, trace	17 participants
20 mg Sumatriptan Nasal Powder	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)	Protein, Visit 4, 1+	3 participants
20 mg Sumatriptan Nasal Powder	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)	Protein, Visit 4, 2+	0 participants
20 mg Sumatriptan Nasal Powder	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)	Glucose, Baseline, negative	132 participants
20 mg Sumatriptan Nasal Powder	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)	Glucose, Baseline, trace	1 participants
20 mg Sumatriptan Nasal Powder	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)	Glucose, Baseline, 3+	0 participants
20 mg Sumatriptan Nasal Powder	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)	Glucose, Visit 3, negative	107 participants
20 mg Sumatriptan Nasal Powder	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)	Glucose, Visit 3, trace	0 participants
20 mg Sumatriptan Nasal Powder	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)	Glucose, Visit 3, 3+	1 participants
20 mg Sumatriptan Nasal Powder	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)	Glucose, Visit 4, negative	122 participants
20 mg Sumatriptan Nasal Powder	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)	Glucose, Visit 4, trace	0 participants
20 mg Sumatriptan Nasal Powder	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)	Glucose, Visit 4, 1+	1 participants
20 mg Sumatriptan Nasal Powder	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)	Glucose, Visit 4, 3+	1 participants
20 mg Sumatriptan Nasal Powder	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)	Ketones, Baseline, negative	124 participants
20 mg Sumatriptan Nasal Powder	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)	Ketones, Baseline, trace	7 participants
20 mg Sumatriptan Nasal Powder	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)	Ketones, Baseline, 1+	0 participants
20 mg Sumatriptan Nasal Powder	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)	Ketones, Baseline, 2+	2 participants
20 mg Sumatriptan Nasal Powder	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)	Ketones, Visit 3, negative	102 participants
20 mg Sumatriptan Nasal Powder	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)	Ketones, Visit 3, trace	5 participants
20 mg Sumatriptan Nasal Powder	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)	Ketones, Visit 3, 1+	1 participants
20 mg Sumatriptan Nasal Powder	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)	Ketones, Visit 3, 2+	0 participants
20 mg Sumatriptan Nasal Powder	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)	Ketones, Visit 4, negative	119 participants
20 mg Sumatriptan Nasal Powder	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)	Ketones, Visit 4, trace	3 participants
20 mg Sumatriptan Nasal Powder	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)	Ketones, Visit 4, 1+	2 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Baseline, negative	116 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Baseline, trace	7 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Baseline, 1+	2 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Baseline, 2+	5 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Baseline, 3+	3 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Visit 3, negative	94 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Visit 3, trace	4 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Visit 3, 1+	5 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Visit 3, 2+	2 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Visit 3, 3+	3 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Visit 4, negative	111 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Visit 4, trace	3 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Visit 4, 1+	1 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Visit 4, 2+	4 participants
20 mg Sumatriptan Nasal Powder	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)	Blood, Visit 4, 3+	5 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Baseline, negative	99 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Baseline, trace	12 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Baseline, 1+	12 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Baseline, 2+	7 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Baseline, 3+	3 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Visit 3, negative	90 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Visit 3, trace	8 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Visit 3, 1+	4 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Visit 3, 2+	5 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Visit 3, 3+	1 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Visit 4, negative	105 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Visit 4, trace	5 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Visit 4, 1+	4 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Visit 4, 2+	8 participants
20 mg Sumatriptan Nasal Powder	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)	WBCs, Visit 4, 3+	2 participants
100 mg Sumatriptan Tablet	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)	Ketones, Visit 4, trace	8 participants
100 mg Sumatriptan Tablet	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)	Protein, Baseline, negative	105 participants
100 mg Sumatriptan Tablet	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)	Blood, Visit 4, 3+	1 participants
100 mg Sumatriptan Tablet	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)	Protein, Baseline, trace	19 participants
100 mg Sumatriptan Tablet	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)	Ketones, Visit 4, 1+	0 participants
100 mg Sumatriptan Tablet	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)	Protein, Baseline, 1+	3 participants
100 mg Sumatriptan Tablet	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)	WBCs, Visit 3, 1+	4 participants
100 mg Sumatriptan Tablet	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)	Protein, Baseline, 2+	2 participants
100 mg Sumatriptan Tablet	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)	Blood, Baseline, negative	116 participants
100 mg Sumatriptan Tablet	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)	Protein, Visit 3, negative	75 participants
100 mg Sumatriptan Tablet	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)	WBCs, Baseline, negative	101 participants
100 mg Sumatriptan Tablet	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)	Protein, Visit 3, trace	15 participants
100 mg Sumatriptan Tablet	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)	Blood, Baseline, trace	4 participants
100 mg Sumatriptan Tablet	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)	Protein, Visit 3, 1+	5 participants
100 mg Sumatriptan Tablet	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)	WBCs, Visit 4, trace	7 participants
100 mg Sumatriptan Tablet	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)	Protein, Visit 3, 2+	0 participants
100 mg Sumatriptan Tablet	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)	Blood, Baseline, 1+	3 participants
100 mg Sumatriptan Tablet	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)	Protein, Visit 4, negative	90 participants
100 mg Sumatriptan Tablet	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)	WBCs, Baseline, trace	8 participants
100 mg Sumatriptan Tablet	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)	Protein, Visit 4, trace	12 participants
100 mg Sumatriptan Tablet	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)	Blood, Baseline, 2+	1 participants
100 mg Sumatriptan Tablet	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)	Protein, Visit 4, 1+	6 participants
100 mg Sumatriptan Tablet	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)	WBCs, Visit 3, 2+	6 participants
100 mg Sumatriptan Tablet	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)	Protein, Visit 4, 2+	1 participants
100 mg Sumatriptan Tablet	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)	Blood, Baseline, 3+	5 participants
100 mg Sumatriptan Tablet	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)	Glucose, Baseline, negative	126 participants
100 mg Sumatriptan Tablet	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)	WBCs, Baseline, 1+	11 participants
100 mg Sumatriptan Tablet	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)	Glucose, Baseline, trace	2 participants
100 mg Sumatriptan Tablet	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)	Blood, Visit 3, negative	78 participants
100 mg Sumatriptan Tablet	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)	Glucose, Baseline, 3+	1 participants
100 mg Sumatriptan Tablet	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)	WBCs, Visit 4, 2+	8 participants
100 mg Sumatriptan Tablet	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)	Glucose, Visit 3, negative	94 participants
100 mg Sumatriptan Tablet	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)	Blood, Visit 3, trace	6 participants
100 mg Sumatriptan Tablet	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)	Glucose, Visit 3, trace	1 participants
100 mg Sumatriptan Tablet	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)	WBCs, Baseline, 2+	5 participants
100 mg Sumatriptan Tablet	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)	Glucose, Visit 3, 3+	0 participants
100 mg Sumatriptan Tablet	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)	Blood, Visit 3, 1+	4 participants
100 mg Sumatriptan Tablet	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)	Glucose, Visit 4, negative	108 participants
100 mg Sumatriptan Tablet	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)	WBCs, Visit 3, 3+	3 participants
100 mg Sumatriptan Tablet	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)	Glucose, Visit 4, trace	1 participants
100 mg Sumatriptan Tablet	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)	Blood, Visit 3, 2+	2 participants
100 mg Sumatriptan Tablet	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)	Glucose, Visit 4, 1+	0 participants
100 mg Sumatriptan Tablet	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)	WBCs, Baseline, 3+	4 participants
100 mg Sumatriptan Tablet	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)	Glucose, Visit 4, 3+	0 participants
100 mg Sumatriptan Tablet	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)	Blood, Visit 3, 3+	5 participants
100 mg Sumatriptan Tablet	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)	Ketones, Baseline, negative	121 participants
100 mg Sumatriptan Tablet	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)	WBCs, Visit 4, 1+	5 participants
100 mg Sumatriptan Tablet	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)	Ketones, Baseline, trace	7 participants
100 mg Sumatriptan Tablet	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)	Blood, Visit 4, negative	94 participants
100 mg Sumatriptan Tablet	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)	Ketones, Baseline, 1+	1 participants
100 mg Sumatriptan Tablet	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)	WBCs, Visit 3, negative	75 participants
100 mg Sumatriptan Tablet	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)	Ketones, Baseline, 2+	0 participants
100 mg Sumatriptan Tablet	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)	Blood, Visit 4, trace	6 participants
100 mg Sumatriptan Tablet	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)	Ketones, Visit 3, negative	88 participants
100 mg Sumatriptan Tablet	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)	WBCs, Visit 4, negative	85 participants
100 mg Sumatriptan Tablet	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)	Ketones, Visit 3, trace	6 participants
100 mg Sumatriptan Tablet	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)	Blood, Visit 4, 1+	5 participants
100 mg Sumatriptan Tablet	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)	Ketones, Visit 3, 1+	0 participants
100 mg Sumatriptan Tablet	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)	WBCs, Visit 3, trace	7 participants
100 mg Sumatriptan Tablet	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)	Ketones, Visit 3, 2+	1 participants
100 mg Sumatriptan Tablet	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)	Blood, Visit 4, 2+	3 participants
100 mg Sumatriptan Tablet	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)	Ketones, Visit 4, negative	101 participants
100 mg Sumatriptan Tablet	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)	WBCs, Visit 4, 3+	4 participants

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.

Time frame: up to 24 weeks

Population: Safety Analysis Set

Arm	Measure	Group	Value (NUMBER)
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antiepileptics	5 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Agents acting on the renin-angiotensin system	12 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Other therapeutic products	2 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Allergens	3 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Anabolic agents for systemic use	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Analgesics	143 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Anesthetics	6 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Anti-acne preparations	2 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Anti-Parkinson drugs	3 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antianemic preparations	18 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antibacterials for systemic use	13 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antibiotics and chemotherapeutics for derm. use	0 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antidiarrrheals, intestinal antiinflammatories	7 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antiemetics and antinauseants	11 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Any concomitant medication	218 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antigout preparations	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antihistamines for systemic use	38 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antiinflammatory and antirheumatic products	135 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antimyotics for systemic use	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antiobesity preparations, exluding diet products	3 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Vitamins	57 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antiprotozoals	0 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antiseptics and disinfectants	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antithrombotic agents	8 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Antivirals for systemic use	2 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Beta blocking agents	18 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Calcium channel blockers	9 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Cardiac therapy	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Corticosteroids for systemic use	7 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Corticosteroids, dermatologic preparations	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Cough and cold preparations	8 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Diuretics	6 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Drugs for acid related disorders	22 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Drugs for functional gastrointestinal disorders	5 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Drugs for obstructive airways diseases	20 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Drugs for treatment of bone diseases	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Drugs used in diabetes	7 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Ectoparasiticides, incl. scabacides, insecticides	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Gynecological antiinfectives and antiseptics	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Immune sera and immunoglobulins	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Laxatives	4 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Lipid modifying agents	23 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Mineral supplements	20 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Muscle relaxants	12 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Nasal preparations	25 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Opthalmologicals	7 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Other alimentary tract and metabolism products	5 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Other dermatological preparations	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Other gynecologicals	21 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Other nervous system drugs	3 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Otologicals	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Psychoanaleptics	57 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Psycholeptics	31 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Sex hormones and modulators of the genital system	62 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Thyroid therapy	18 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Unspecified herbal and traditional medicine	11 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Urologicals	3 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Concomitant Medications	Vaccines	1 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Corticosteroids, dermatologic preparations	1 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Any concomitant medication	226 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Nasal preparations	27 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Agents acting on the renin-angiotensin system	14 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Cough and cold preparations	9 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Other therapeutic products	2 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Unspecified herbal and traditional medicine	12 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Allergens	4 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Diuretics	7 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Anabolic agents for systemic use	1 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Opthalmologicals	6 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Analgesics	148 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Drugs for acid related disorders	23 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Anesthetics	6 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Psycholeptics	31 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Anti-acne preparations	2 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Drugs for functional gastrointestinal disorders	3 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Anti-Parkinson drugs	3 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Other alimentary tract and metabolism products	5 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antianemic preparations	20 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Drugs for obstructive airways diseases	26 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antibacterials for systemic use	17 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Vaccines	2 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antibiotics and chemotherapeutics for derm. use	2 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Drugs for treatment of bone diseases	1 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antidiarrrheals, intestinal antiinflammatories	6 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Other dermatological preparations	1 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antiemetics and antinauseants	12 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Drugs used in diabetes	9 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antiepileptics	4 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Sex hormones and modulators of the genital system	59 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antigout preparations	1 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Ectoparasiticides, incl. scabacides, insecticides	0 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antihistamines for systemic use	39 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Other gynecologicals	21 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antiinflammatory and antirheumatic products	143 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Gynecological antiinfectives and antiseptics	2 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antimyotics for systemic use	3 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Urologicals	4 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Immune sera and immunoglobulins	1 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antiobesity preparations, exluding diet products	3 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Other nervous system drugs	3 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antiprotozoals	1 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Laxatives	3 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antiseptics and disinfectants	0 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Thyroid therapy	16 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antithrombotic agents	8 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Lipid modifying agents	20 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Antivirals for systemic use	3 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Otologicals	0 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Beta blocking agents	15 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Mineral supplements	22 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Calcium channel blockers	8 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Vitamins	56 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Cardiac therapy	1 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Muscle relaxants	16 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Corticosteroids for systemic use	8 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Concomitant Medications	Psychoanaleptics	60 participants

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)

Time frame: Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)

Population: Safety Analysis Set

Arm	Measure	Group	Value (NUMBER)
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Baseline, CS; n=133, 129	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Baseline, CNS; n=133, 129	132 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Visit 3, CS; n=110, 95	1 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Visit 3, CNS; n=110, 95	109 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Visit 4, CS; n=124, 111	0 participants
20 mg Sumatriptan Nasal Powder	Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Visit 4, CNS; n=124, 111	124 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Visit 4, CS; n=124, 111	0 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Baseline, CS; n=133, 129	0 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Visit 3, CNS; n=110, 95	93 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Baseline, CNS; n=133, 129	129 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Visit 4, CNS; n=124, 111	111 participants
100 mg Sumatriptan Tablet	Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)	Visit 3, CS; n=110, 95	2 participants

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.

Time frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)

Population: FAS. The LOCF imputation method was used for this analysis.

Arm	Measure	Group	Value (NUMBER)
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Freedom Was Achieved	60 minutes post-dose	41.2 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Freedom Was Achieved	10 minutes post-dose	2.5 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Freedom Was Achieved	15 minutes post-dose	7.2 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Freedom Was Achieved	30 minutes post-dose	18.2 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Freedom Was Achieved	45 minutes post-dose	31.0 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Freedom Was Achieved	90 minutes post-dose	52.8 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Freedom Was Achieved	120 minutes post-dose	60.4 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Freedom Was Achieved	90 minutes post-dose	44.9 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Freedom Was Achieved	45 minutes post-dose	21.3 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Freedom Was Achieved	10 minutes post-dose	1.3 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Freedom Was Achieved	60 minutes post-dose	32.9 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Freedom Was Achieved	15 minutes post-dose	3.7 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Freedom Was Achieved	120 minutes post-dose	56.3 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Freedom Was Achieved	30 minutes post-dose	10.8 percentage of attacks

p-value: 0.177195% CI: [0.76, 4.54]ANCOVA

p-value: 0.007795% CI: [1.21, 3.42]ANCOVA

p-value: 0.000395% CI: [1.32, 2.5]ANCOVA

p-value: <0.000195% CI: [1.29, 2.09]ANCOVA

p-value: 0.001695% CI: [1.14, 1.74]ANCOVA

p-value: 0.005995% CI: [1.09, 1.69]ANCOVA

p-value: 0.271795% CI: [0.91, 1.42]ANCOVA

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.

Time frame: 10, 15, 30, 45, 60, 90, and 120 minutes

Population: FAS. The LOCF imputation method was used in this analysis.

Arm	Measure	Group	Value (NUMBER)
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Reduction Was Achieved	30 minutes post-dose	49.0 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Reduction Was Achieved	60 minutes post-dose	67.2 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Reduction Was Achieved	15 minutes post-dose	26.4 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Reduction Was Achieved	90 minutes post-dose	74.6 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Reduction Was Achieved	45 minutes post-dose	60.7 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Reduction Was Achieved	120 minutes post-dose	78.0 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Reduction Was Achieved	10 minutes post-dose	11.5 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Reduction Was Achieved	120 minutes post-dose	75.2 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Reduction Was Achieved	10 minutes post-dose	10.2 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Reduction Was Achieved	15 minutes post-dose	19.6 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Reduction Was Achieved	30 minutes post-dose	35.2 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Reduction Was Achieved	45 minutes post-dose	49.9 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Reduction Was Achieved	60 minutes post-dose	59.8 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Reduction Was Achieved	90 minutes post-dose	69.8 percentage of attacks

p-value: 0.354995% CI: [0.85, 1.6]ANCOVA

p-value: 0.000595% CI: [1.2, 1.9]ANCOVA

p-value: <0.000195% CI: [1.45, 2.21]ANCOVA

p-value: 0.000295% CI: [1.24, 1.96]ANCOVA

p-value: 0.005795% CI: [1.1, 1.71]ANCOVA

p-value: 0.065495% CI: [0.99, 1.61]ANCOVA

p-value: 0.289495% CI: [0.89, 1.49]ANCOVA

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.

Time frame: Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)

Population: FAS. The LOCF imputation method was used in this analysis.

Arm	Measure	Group	Value (NUMBER)
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Relief Was Achieved	30 minutes post-dose	53.8 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Relief Was Achieved	60 minutes post-dose	72.1 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Relief Was Achieved	15 minutes post-dose	27.9 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Relief Was Achieved	90 minutes post-dose	77.4 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Relief Was Achieved	45 minutes post-dose	65.0 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Relief Was Achieved	120 minutes post-dose	79.6 percentage of attacks
20 mg Sumatriptan Nasal Powder	Percentage of Attacks in Which Pain Relief Was Achieved	10 minutes post-dose	13.8 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Relief Was Achieved	120 minutes post-dose	76.9 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Relief Was Achieved	10 minutes post-dose	11.5 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Relief Was Achieved	15 minutes post-dose	20.9 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Relief Was Achieved	30 minutes post-dose	38.7 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Relief Was Achieved	45 minutes post-dose	53.9 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Relief Was Achieved	60 minutes post-dose	62.6 percentage of attacks
100 mg Sumatriptan Tablet	Percentage of Attacks in Which Pain Relief Was Achieved	90 minutes post-dose	72.0 percentage of attacks

p-value: 0.242695% CI: [0.87, 1.77]ANCOVA

p-value: 0.006995% CI: [1.12, 1.99]ANCOVA

p-value: <0.000195% CI: [1.47, 2.56]ANCOVA

p-value: 0.000495% CI: [1.26, 2.23]ANCOVA

p-value: 0.000895% CI: [1.22, 2.11]ANCOVA

p-value: 0.027295% CI: [1.04, 1.83]ANCOVA

p-value: 0.208595% CI: [0.9, 1.62]ANCOVA

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Mean Sum of Migraine Pain Intensity Differences (SPID)-30

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 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 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 Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)

Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)

Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 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 Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)

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 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 Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)

Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)

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 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)

Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose

Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose

Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe

Median Time to Pain Freedom

Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event

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)

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)

Number of Participants With the Indicated Concomitant Medications

Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)

Percentage of Attacks in Which Pain Freedom Was Achieved

Percentage of Attacks in Which Pain Reduction Was Achieved

Percentage of Attacks in Which Pain Relief Was Achieved