Trial Outcomes & Findings for A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine (NCT NCT04406649)
NCT ID: NCT04406649
Last Updated: 2023-07-03
Results Overview
The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
482 participants
Primary outcome timeframe
At Month 12 of Study Medication Dosing
Results posted on
2023-07-03
Participant Flow
The study was conducted at 54 sites in the United States.
A total of 482 participants were enrolled in the study (all enrolled subjects population).
Participant milestones
| Measure |
STS101 5.2 mg
Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.
|
|---|---|
|
Overall Study
STARTED
|
482
|
|
Overall Study
COMPLETED
|
205
|
|
Overall Study
NOT COMPLETED
|
277
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine
Baseline characteristics by cohort
| Measure |
STS101 5.2 mg
n=446 Participants
Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.
|
|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
389 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
379 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
446 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 12 of Study Medication DosingThe subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).
Outcome measures
| Measure |
STS101 5.2 mg
n=183 Participants
Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.
|
|---|---|
|
Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)
|
40.0 Participants
|
PRIMARY outcome
Timeframe: At Month 12 of Study Drug AdministrationSubjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack.
Outcome measures
| Measure |
STS101 5.2 mg
n=183 Participants
Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.
|
|---|---|
|
Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)
|
60 Participants
|
Adverse Events
STS101 5.2 mg
Serious events: 3 serious events
Other events: 206 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
STS101 5.2 mg
n=446 participants at risk
Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.
|
|---|---|
|
Cardiac disorders
Acute Myocardial infarction
|
0.22%
1/446 • Adverse event data was collected for 1 year.
The all subjects (Mk1/Mk2 device) safety population was used for adverse event reporting.
|
|
Cardiac disorders
Postural Orthostatic Tachycardia Syndrome
|
0.22%
1/446 • Adverse event data was collected for 1 year.
The all subjects (Mk1/Mk2 device) safety population was used for adverse event reporting.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.22%
1/446 • Adverse event data was collected for 1 year.
The all subjects (Mk1/Mk2 device) safety population was used for adverse event reporting.
|
Other adverse events
| Measure |
STS101 5.2 mg
n=446 participants at risk
Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
14.3%
64/446 • Adverse event data was collected for 1 year.
The all subjects (Mk1/Mk2 device) safety population was used for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.7%
30/446 • Adverse event data was collected for 1 year.
The all subjects (Mk1/Mk2 device) safety population was used for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.2%
23/446 • Adverse event data was collected for 1 year.
The all subjects (Mk1/Mk2 device) safety population was used for adverse event reporting.
|
|
Infections and infestations
COVID-19
|
5.6%
25/446 • Adverse event data was collected for 1 year.
The all subjects (Mk1/Mk2 device) safety population was used for adverse event reporting.
|
|
Nervous system disorders
Dysgeusia
|
7.4%
33/446 • Adverse event data was collected for 1 year.
The all subjects (Mk1/Mk2 device) safety population was used for adverse event reporting.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
31/446 • Adverse event data was collected for 1 year.
The all subjects (Mk1/Mk2 device) safety population was used for adverse event reporting.
|
Additional Information
Vice President of Regulatory Affairs and Quality
Satsuma Pharmaceuticals, Inc.
Phone: 650-837-0799
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER