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

ClinicalTrials.gov processed this data on June 30, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
 (See Contacts and Locations)
Verified June 2023 by Satsuma Pharmaceuticals, Inc.

Sponsor

Satsuma Pharmaceuticals, Inc.

Information Provided by (Responsible Party)

Satsuma Pharmaceuticals, Inc.

Clinicaltrials.gov Identifier

NCT04406649
Other Study ID Numbers: STS101-003
First Submitted: May 20, 2020
First Posted: May 28, 2020
Results First Posted: July 3, 2023
Last Update Posted: July 3, 2023
Last Verified: June 2023
History of Changes

Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.

ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.

Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.

Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.

For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.

See also the Web Policies and Notices for the NIH web site.

Study 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.
Condition or Disease Intervention/Treatment
  • Migraine
  • Migraine With Aura
  • Migraine Without Aura
  • Drug: Dihydroergotamine

Study Design

Study TypeInterventional
Actual Enrollment482 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open-Label, 12-Month Study to Evaluate the Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine
Study Start DateSeptember 14, 2020
Actual Primary Completion DateJanuary 16, 2023
Actual Study Completion DateJanuary 16, 2023

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • STS101
    • STS101 (dihydroergotamine nasal powder)
  • Drug: Dihydroergotamine
    • Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population) [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).
  2. Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population) [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.

Eligibility Criteria

Ages Eligible for Study 18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study All
Accepts Healthy Volunteers No
Inclusion Criteria
  • a:
  • 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)
  • Ke
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.

Contacts and Locations

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

    Study Documents (Full Text)

    More Information

    Additional Relevant MeSH Terms

    • Migraine Disorders
    • Migraine without Aura
    • Migraine with Aura
    • Headache Disorders, Primary
    • Headache Disorders
    • Brain Diseases
    • Central Nervous System Diseases
    • Nervous System Diseases