Trial Outcomes & Findings for A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine (NCT NCT04940390)

Last Updated: 2023-11-27

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

1591 participants

Primary outcome timeframe

2 Hours Post-Dose

Results posted on

2023-11-27

Participant Flow

A total of 1591 participants were randomized in the study, of which 1424 reported a qualifying migraine attack, received study drug, and reported efficacy data in at least one post-treatment e-diary (modified intent to treat population).

Participant milestones

Participant milestones
Measure	STS101 5.2 mg Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg	STS101 Placebo Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder)
Overall Study STARTED	796	795
Overall Study Modified Intent-to Treat Population	716	708
Overall Study Safety Population	731	729
Overall Study COMPLETED	771	770
Overall Study NOT COMPLETED	25	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STS101 5.2 mg n=716 Participants Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg	STS101 Placebo n=708 Participants Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder)	Total n=1424 Participants Total of all reporting groups
Age, Customized 18-35 years	312 Participants n=5 Participants	297 Participants n=7 Participants	609 Participants n=5 Participants
Age, Customized >35-50 years	286 Participants n=5 Participants	283 Participants n=7 Participants	569 Participants n=5 Participants
Age, Customized >50-65 years	118 Participants n=5 Participants	128 Participants n=7 Participants	246 Participants n=5 Participants
Sex: Female, Male Female	567 Participants n=5 Participants	564 Participants n=7 Participants	1131 Participants n=5 Participants
Sex: Female, Male Male	149 Participants n=5 Participants	144 Participants n=7 Participants	293 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	86 Participants n=5 Participants	97 Participants n=7 Participants	183 Participants n=5 Participants
Race (NIH/OMB) White	591 Participants n=5 Participants	576 Participants n=7 Participants	1167 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	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	716 participants n=5 Participants	708 participants n=7 Participants	1424 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 Hours Post-Dose

Population: The analysis was performed on the mITT population.

Outcome measures

Outcome measures
Measure	STS101 5.2 mg n=716 Participants Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg	STS101 Placebo n=708 Participants Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder)
Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose	146 Participants	124 Participants

PRIMARY outcome

Timeframe: 2 Hours Post-Dose

Population: This analysis was conducted on the mITT population.

Subjects 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

Outcome measures
Measure	STS101 5.2 mg n=716 Participants Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg	STS101 Placebo n=708 Participants Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder)
Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose	265 Participants	230 Participants

SECONDARY outcome

Timeframe: 2 Hours Post Dose

Population: This analysis was conducted on the mITT population.

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 relief means the pain went from moderate (2) or severe (3) to mild pain (1) or no pain (0).

Outcome measures

Outcome measures
Measure	STS101 5.2 mg n=716 Participants Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg	STS101 Placebo n=708 Participants Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder)
Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose	379 Participants	316 Participants

Adverse Events

STS101 5.2 mg

Serious events: 3 serious events

Other events: 111 other events

Deaths: 0 deaths

STS101 Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	STS101 5.2 mg n=731 participants at risk Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg	STS101 Placebo n=729 participants at risk Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder)
Psychiatric disorders Suicide Attempt	0.14% 1/731 • Number of events 1 • Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66. The safety population was used for adverse event reporting.	0.00% 0/729 • Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66. The safety population was used for adverse event reporting.
Injury, poisoning and procedural complications Procedural Abdominal Pain Post-hysterectomy	0.14% 1/731 • Number of events 1 • Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66. The safety population was used for adverse event reporting.	0.00% 0/729 • Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66. The safety population was used for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Asthma Exacerbation/Pneumonia	0.14% 1/731 • Number of events 1 • Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66. The safety population was used for adverse event reporting.	0.00% 0/729 • Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66. The safety population was used for adverse event reporting.

Other adverse events

Other adverse events
Measure	STS101 5.2 mg n=731 participants at risk Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg	STS101 Placebo n=729 participants at risk Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder)
Respiratory, thoracic and mediastinal disorders Nasal Discomfort	8.3% 61/731 • Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66. The safety population was used for adverse event reporting.	1.5% 11/729 • Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66. The safety population was used for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	3.1% 23/731 • Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66. The safety population was used for adverse event reporting.	0.14% 1/729 • Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66. The safety population was used for adverse event reporting.
Nervous system disorders Dysgeusia	3.7% 27/731 • Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66. The safety population was used for adverse event reporting.	0.27% 2/729 • Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66. The 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