A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine (ASCEND)

June 30, 2023 updated by: Satsuma Pharmaceuticals, Inc.

An Open-Label, 12-Month Study to Evaluate the Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine

Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The ASCEND trial is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.

Study Type

Interventional

Enrollment (Actual)

482

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encino, California, United States, 91316
        • WR-PRI
      • Long Beach, California, United States, 90806
        • Collaborative Neuroscience
      • Los Alamitos, California, United States, 90720
        • WR-PRI
      • Los Angeles, California, United States, 90048
        • Clinical Research Institute
      • Los Angeles, California, United States, 90017
        • Downtown LA Research
      • Newport Beach, California, United States, 92660
        • WR-PRI
    • Florida
      • DeLand, Florida, United States, 32720
        • Hillcrest Medical Research
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Lake City, Florida, United States, 32055
        • Multi-Specialty Research Associates
      • Maitland, Florida, United States, 32751
        • ClinCloud
      • Miami, Florida, United States, 33155
        • Biotech Pharmaceuticals
      • Miami Lakes, Florida, United States, 33061
        • Behavioral Clinical Research
      • Orlando, Florida, United States, 32801
        • CNS Health Care - Orlando
      • Ormond Beach, Florida, United States, 32174
        • Complete Health Research
      • Sunrise, Florida, United States, 33351
        • Infinity Clinical Research
      • Tampa, Florida, United States, 33615
        • Santos Research Center, CORP
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
      • Winter Haven, Florida, United States, 33880
        • Clinical Research CF
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Integrated Clinical Trial Services, Inc
    • Louisiana
      • Prairieville, Louisiana, United States, 70769
        • DelRicht Research
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Medvadis Research at Boston PainCare Center
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Healthcare Research Network
      • Springfield, Missouri, United States, 65810
        • Clinvest Research
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89118
        • Wake Research - Clinical Research Center of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Neurology Headache Clinic
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • Brooklyn, New York, United States, 11235
        • SPRI Clinical Research
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • CTI Clinical Research Center
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research
      • Dayton, Ohio, United States, 45459
        • Neurology Diagnosis
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • DelRicht Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University/Jefferson Headache Center
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • CNS Healthcare - Memphis
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology
      • Tomball, Texas, United States, 77375
        • DM Clinical Research
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research
      • McLean, Virginia, United States, 22101
        • Georgetown University Hospital, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Males or females, 18-65 years of age at the time of Screening Visit
  • Subject has at least 1-year history of migraines (with or without aura), according to the
  • International Classification of Headache Disorder, 3rd Edition (ICHD3)

Key Exclusion Criteria:

  • Pregnant or breast-feeding women
  • Women of child-bearing potential not using or not willing to use highly effective contraception.
  • Diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines or cluster headache.
  • History of coronary artery disease, coronary artery vasospasm (including Printz-metals' angina), clinically significant arrhythmia or, peripheral vascular disease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary intervention, or cardiac surgery.
  • History of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage.
  • Diagnosis of major depression with current symptoms, psychosis, alcohol abuse or dependence, drug abuse or dependence, major psychiatric conditions (e.g. schizophrenia, psychosis or Bipolar disorder), dementia. Other significant neurological or psychiatric disorders (including other pain syndromes or risk of suicide) that in the opinion of the investigator might interfere with study participation and assessments or subject safety.
  • Any clinically significant symptoms or conditions, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator might interfere with study assessments or safety of participant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STS101
STS101 (dihydroergotamine nasal powder)
Drug: Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Names:
  • Dihydroergotamine Mesylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)
Time Frame: At Month 12 of Study Medication Dosing
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).
At Month 12 of Study Medication Dosing
Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)
Time Frame: At Month 12 of Study Drug Administration
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.
At Month 12 of Study Drug Administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Freedom
Time Frame: Up to 48 hours post-dosing
Proportion of subjects free from headache pain (defined as moderate or severe headache pain becoming none on a 4-point scale)
Up to 48 hours post-dosing
Freedom From Most-Bothersome Symptom
Time Frame: Up to 48 hours post-dosing
Proportion of subjects free from most bothersome symptom (MBS) among photophobia, phonophobia and nausea
Up to 48 hours post-dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Satsuma Pharmaceuticals, Inc.

Investigators

  • Study Chair: Detlef Albrecht, MD, Satsuma Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Actual)

January 16, 2023

Study Completion (Actual)

January 16, 2023

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STS101-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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