Trial Outcomes & Findings for A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine (NCT NCT03901482)

Last Updated: 2023-06-29

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

1201 participants

Primary outcome timeframe

2 Hours Post-Dose

Results posted on

2023-06-29

Participant Flow

The study was conducted at 119 sites in the United States.

A total of 1201 participants were randomized in the study, of which 1065 reported a qualifying migraine attack, received study drug, and reported a post-dose efficacy evaluation for at least one time point at or before the 2-hour timepoint (mITT population).

Participant milestones

Participant milestones
Measure	STS101 Low Dose Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 3.9 mg.	STS101 High Dose 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	399	400	402
Overall Study COMPLETED	363	368	364
Overall Study NOT COMPLETED	36	32	38

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STS101 Low Dose n=363 Participants Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 3.9 mg.	STS101 High Dose n=367 Participants Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.	STS101 Placebo n=363 Participants Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder).	Total n=1093 Participants Total of all reporting groups
Age, Customized Age Group (n (%)) · 18-35 years	123 Participants n=5 Participants	117 Participants n=7 Participants	122 Participants n=5 Participants	362 Participants n=4 Participants
Age, Customized Age Group (n (%)) · >30-50 years	164 Participants n=5 Participants	186 Participants n=7 Participants	176 Participants n=5 Participants	526 Participants n=4 Participants
Age, Customized Age Group (n (%)) · >50-65 years	76 Participants n=5 Participants	64 Participants n=7 Participants	65 Participants n=5 Participants	205 Participants n=4 Participants
Sex: Female, Male Female	318 Participants n=5 Participants	320 Participants n=7 Participants	317 Participants n=5 Participants	955 Participants n=4 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	47 Participants n=7 Participants	46 Participants n=5 Participants	138 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	31 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Black or African American	55 Participants n=5 Participants	60 Participants n=7 Participants	41 Participants n=5 Participants	156 Participants n=4 Participants
Race (NIH/OMB) White	293 Participants n=5 Participants	292 Participants n=7 Participants	304 Participants n=5 Participants	889 Participants n=4 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment United States	363 participants n=5 Participants	367 participants n=7 Participants	363 participants n=5 Participants	1093 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 Hours Post-Dose

Population: The analysis was performed on the mITT population.

Outcome measures

Outcome measures
Measure	STS101 Low Dose n=354 Participants Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 3.9 mg.	STS101 High Dose n=353 Participants Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.	STS101 Placebo n=358 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	69 Participants	68 Participants	53 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 Low Dose n=354 Participants Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 3.9 mg.	STS101 High Dose n=353 Participants Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.	STS101 Placebo n=358 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	133 Participants	139 Participants	119 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 Low Dose n=354 Participants Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 3.9 mg.	STS101 High Dose n=353 Participants Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.	STS101 Placebo n=358 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	180 Participants	177 Participants	166 Participants

Adverse Events

STS101 Low Dose

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

STS101 High Dose

Serious events: 1 serious events

Other events: 52 other events

Deaths: 0 deaths

STS101 Placebo

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	STS101 Low Dose n=363 participants at risk Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 3.9 mg.	STS101 High Dose n=367 participants at risk Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.	STS101 Placebo n=363 participants at risk Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder).
Infections and infestations Pneumonia	0.00% 0/363 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.	0.27% 1/367 • Number of events 1 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.	0.00% 0/363 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.

Other adverse events

Other adverse events
Measure	STS101 Low Dose n=363 participants at risk Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 3.9 mg.	STS101 High Dose n=367 participants at risk Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.	STS101 Placebo n=363 participants at risk Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder).
Respiratory, thoracic and mediastinal disorders Nasal Discomfort	5.5% 20/363 • Number of events 20 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.	5.7% 21/367 • Number of events 21 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.	1.9% 7/363 • Number of events 7 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.
Nervous system disorders Dyseusia	4.1% 15/363 • Number of events 15 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.	4.9% 18/367 • Number of events 18 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.	1.4% 5/363 • Number of events 5 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	2.5% 9/363 • Number of events 9 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.	1.4% 5/367 • Number of events 5 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.	1.1% 4/363 • Number of events 4 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	1.4% 5/363 • Number of events 5 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.	2.2% 8/367 • Number of events 8 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). The safety population was used for adverse event reporting.	0.83% 3/363 • Number of events 3 • Serious adverse events (SAEs) were collected from informed consent up to the end of study, and adverse events (AEs) were collected from randomization up to the end of the study (7±3 days after migraine treatment or early study termination). 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