Trial · NCT04940390
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine
NCT04940390, Phase 3, Completed, Satsuma Pharmaceuticals, Inc.; results first posted 2023-07-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine. Trials, record NCT04940390. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04940390
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine
- NCT number
- NCT04940390
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,591 participants, actual
- Lead sponsor
- Satsuma Pharmaceuticals, Inc.
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Interventions
- Dihydroergotamine, Placebo
- First posted
- 2021-06-25
- Last updated
- 2023-11-27
- Results first posted
- 2023-07-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose | 2 Hours Post-Dose | 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). |
| Primary | Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose | 2 Hours Post-Dose | 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. |
| Secondary | Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose | 2 Hours Post Dose | 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). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose | 2 Hours Post-Dose | The analysis was performed on the mITT population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose | 2 Hours Post-Dose | This analysis was conducted on the mITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose | 2 Hours Post Dose | This analysis was conducted on the mITT population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose | STS101 5.2 mg | 146 | Participants | ||
| Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose | STS101 Placebo | 124 | Participants | ||
| Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose | STS101 5.2 mg | 265 | Participants | ||
| Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose | STS101 Placebo | 230 | Participants | ||
| Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose | STS101 5.2 mg | 379 | Participants | ||
| Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose | STS101 Placebo | 316 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | STS101 5.2 mg | 796 | |
| Overall Study | STARTED | STS101 Placebo | 795 | |
| Overall Study | Modified Intent-to Treat Population | STS101 5.2 mg | 716 | |
| Overall Study | Modified Intent-to Treat Population | STS101 Placebo | 708 | |
| Overall Study | Safety Population | STS101 5.2 mg | 731 | |
| Overall Study | Safety Population | STS101 Placebo | 729 | |
| Overall Study | COMPLETED | STS101 5.2 mg | 771 | |
| Overall Study | COMPLETED | STS101 Placebo | 770 | |
| Overall Study | NOT COMPLETED | STS101 5.2 mg | 25 | |
| Overall Study | NOT COMPLETED | STS101 Placebo | 25 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | STS101 5.2 mg | 61 | 731 | |
| other | Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | STS101 Placebo | 11 | 729 | |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | STS101 5.2 mg | 23 | 731 | |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | STS101 Placebo | 1 | 729 | |
| other | Dysgeusia | Nervous system disorders | STS101 5.2 mg | 27 | 731 | |
| other | Dysgeusia | Nervous system disorders | STS101 Placebo | 2 | 729 | |
| serious | Suicide Attempt | Psychiatric disorders | STS101 5.2 mg | 1 | 731 | 1 |
| serious | Suicide Attempt | Psychiatric disorders | STS101 Placebo | 0 | 729 | 0 |
| serious | Procedural Abdominal Pain Post-hysterectomy | Injury, poisoning and procedural complications | STS101 5.2 mg | 1 | 731 | 1 |
| serious | Procedural Abdominal Pain Post-hysterectomy | Injury, poisoning and procedural complications | STS101 Placebo | 0 | 729 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | STS101 5.2 mg | 0 | 731 |
| Total, all-cause mortality | STS101 Placebo | 0 | 729 |
| Total, other adverse events | STS101 5.2 mg | 111 | 731 |
| Total, other adverse events | STS101 Placebo | 14 | 729 |
| Total, serious adverse events | STS101 5.2 mg | 3 | 731 |
| Total, serious adverse events | STS101 Placebo | 0 | 729 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| STS101 5.2 mg vs STS101 Placebo: Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose | Trial comparisons |
| STS101 5.2 mg vs STS101 Placebo: Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose | Trial comparisons |
| STS101 5.2 mg vs STS101 Placebo: Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose | Trial comparisons |
| STS101 5.2 mg vs STS101 Placebo: deaths from any cause | Trial comparisons |
| STS101 5.2 mg vs STS101 Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04940390
GET https://conductscience.org/api/trials/v1/NCT04940390/registered