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Ergot Alkaloid

Dihydroergotamine for Migraine (ASCEND 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
Subject has at least 1-year history of migraines (with or without aura), according to the
Males or females, 18-65 years of age at the time of Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 12 of study medication dosing
Awards & highlights

ASCEND Trial Summary

This trial will study the safety and tolerability of a new drug, STS101, for the acute treatment of migraines. The trial will last 12 months and will be conducted at multiple centers.

Eligible Conditions
  • Migraine

ASCEND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are male or female, 18-65 years of age at the time of Screening Visit.

ASCEND Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 12 of study medication dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 12 of study medication dosing 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 Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)
Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)
Secondary outcome measures
Freedom From Most-Bothersome Symptom
Pain Freedom

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

ASCEND Trial Design

1Treatment groups
Experimental Treatment
Group I: 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

Find a Location

Who is running the clinical trial?

Satsuma Pharmaceuticals, Inc.Lead Sponsor
4 Previous Clinical Trials
2,874 Total Patients Enrolled
4 Trials studying Migraine
2,874 Patients Enrolled for Migraine
Detlef Albrecht, MDStudy ChairSatsuma Pharmaceuticals, Inc.
3 Previous Clinical Trials
2,905 Total Patients Enrolled
2 Trials studying Migraine
2,792 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.

How does Dihydroergotamine compare to other drugs in its class?

"There is currently one Dihydroergotamine study in Phase 3 with 45 clinical trial sites around the world, mostly concentrated in the state of California."

Answered by AI

Are there any more patients needed to complete this clinical trial?

"This study has completed recruitment for patients. The trial was first posted on 9/14/2020 and was most recently edited on 8/5/2022. If you are exploring for other studies, there are currently 177 trials actively searching for patients with migraine and 1 studies for Dihydroergotamine actively searching for participants."

Answered by AI

Are there specific inclusion criteria for this research project?

"This study will be conducted on 482 individuals that suffer from migraines and meet the age criteria of being between 18-65. It's worth mentioning that migraineurs of both genders are eligible for this trial, so long as they have had a history of migraines (with or without aura) for at least one year."

Answered by AI

How many test subjects are included in this clinical trial?

"This clinical trial is not currently looking for new participants. However, this study was last updated on August 5th, 2022 and might open up recruitment in the future. Alternatively, there are presently 177 clinical trials actively searching for participants with migraine and 1 trials for Dihydroergotamine that are enrolling patients right now."

Answered by AI

Could you provide a number for how many sites are participating in this clinical trial?

"This clinical trial is based out of Clin Cloud in Maitland, Florida, Multi-Specialty Research Associates in Lake City, Louisiana and Delricht Research in Prairieville, Massachusetts with 31 other sites participating."

Answered by AI

Has Dihydroergotamine received regulatory approval from the FDA?

"Dihydroergotamine received a safety score of 3 because there is both evidence of efficacy and multiple trials supporting its safety."

Answered by AI

Could you tell me if this research is only applicable to those over 60 years old?

"According to the inclusion criteria laid out by this trial, patients must be aged between 18-65. There are 32 studies available for people who fall below the age bracket and 123 trials for those over 65."

Answered by AI

Has a trial like this been conducted before?

"Dihydroergotamine has been investigated in clinical trials since 2020, when Satsuma Pharmaceuticals, Inc. first sponsored a study of the drug. This initial trial involved 482 patients. After this Phase 3 approval process was completed in 2020, only one active study involving Dihydroergotamine remains; it is also sponsored by Satsuma Pharmaceuticals, Inc.."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
California
Other
New York
How old are they?
18 - 65
What site did they apply to?
Healthcare Research Network
Downtown LA Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~107 spots leftby Mar 2025