Trial Outcomes & Findings for Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents (NCT NCT03338920)
NCT ID: NCT03338920
Last Updated: 2023-07-24
Results Overview
Participants will self-report the severity of their headache.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
159 participants
Primary outcome timeframe
120 minutes
Results posted on
2023-07-24
Participant Flow
Participant milestones
| Measure |
Sumatriptan Nasal Powder
Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).
sumatriptan nasal powder: nasal powder administered via nosepiece
|
Placebo
Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.
Placebo: lactose monohydrate powder administered via nosepiece
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
80
|
|
Overall Study
COMPLETED
|
75
|
74
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
Baseline characteristics by cohort
| Measure |
Sumatriptan Nasal Powder
n=79 Participants
Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).
sumatriptan nasal powder: nasal powder administered via nosepiece
|
Placebo
n=80 Participants
Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.
Placebo: lactose monohydrate powder administered via nosepiece
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
79 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.4 years
n=5 Participants
|
14.4 years
n=7 Participants
|
14.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
57 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
79 participants
n=5 Participants
|
80 participants
n=7 Participants
|
159 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 120 minutesParticipants will self-report the severity of their headache.
Outcome measures
| Measure |
Sumatriptan Nasal Powder
n=79 Participants
Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).
sumatriptan nasal powder: nasal powder administered via nosepiece
|
Placebo
n=80 Participants
Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.
Placebo: lactose monohydrate powder administered via nosepiece
|
|---|---|---|
|
Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment
|
8 Participants
|
9 Participants
|
Adverse Events
Sumatriptan Nasal Powder
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sumatriptan Nasal Powder
n=79 participants at risk
Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).
sumatriptan nasal powder: nasal powder administered via nosepiece
|
Placebo
n=80 participants at risk
Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.
Placebo: lactose monohydrate powder administered via nosepiece
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
2.5%
2/79 • Number of events 2 • up to approximately 28 weeks
|
0.00%
0/80 • up to approximately 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/79 • up to approximately 28 weeks
|
1.2%
1/80 • Number of events 1 • up to approximately 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/79 • up to approximately 28 weeks
|
1.2%
1/80 • Number of events 1 • up to approximately 28 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Burning Sensation
|
1.3%
1/79 • Number of events 1 • up to approximately 28 weeks
|
0.00%
0/80 • up to approximately 28 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place