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Ergot Alkaloids

Dihydroergotamine for Migraine (SUMMIT Trial)

Phase 3
Waitlist Available
Research Sponsored by Satsuma Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours post-dose
Awards & highlights

SUMMIT Trial Summary

This trial is testing a new migraine medication to see if it is effective, safe, and well tolerated.

Eligible Conditions
  • Migraine

SUMMIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose
Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose
Secondary outcome measures
Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose

Side effects data

From 2023 Phase 3 trial • 482 Patients • NCT04406649
14%
Nasal Discomfort
7%
Nasal Congestion
7%
Dysgeusia
7%
Nausea
6%
COVID-19
5%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
STS101 5.2 mg

SUMMIT Trial Design

2Treatment groups
Experimental Treatment
Group I: STS101 PlaceboExperimental Treatment1 Intervention
STS101 Placebo
Group II: STS101Experimental Treatment1 Intervention
STS101 (dihydroergotamine nasal powder)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dihydroergotamine
2021
Completed Phase 3
~3360
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Satsuma Pharmaceuticals, Inc.Lead Sponsor
4 Previous Clinical Trials
1,765 Total Patients Enrolled
4 Trials studying Migraine
1,765 Patients Enrolled for Migraine
Detlef Albrecht, MDStudy ChairSatsuma Pharmaceuticals, Inc.
3 Previous Clinical Trials
1,796 Total Patients Enrolled
2 Trials studying Migraine
1,683 Patients Enrolled for Migraine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
California
Other
Missouri
How old are they?
18 - 65
What site did they apply to?
Hope Clinical Research
Infinity Clinical Research, LLC
Alliance for Multispecialty Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine
2021. "A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04940390.
~424 spots leftby Apr 2025
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