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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified May 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 19, 2020
First Posted
May 27, 2020
Results First Posted
June 11, 2023
Last Update Posted
July 2, 2023
Last Verified
May 2023

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

History of Changes

Study Details

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 DiseaseIntervention/Treatment
MigraineMigraine With AuraMigraine 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 13, 2020
Actual Primary Completion DateJanuary 15, 2023
Actual Study Completion DateJanuary 15, 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)
    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)
    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(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsSatsuma Pharmaceuticals, Inc.
Locations
WR-PRI | Encino California, United States, 91316Collaborative Neuroscience | Long Beach California, United States, 90806WR-PRI | Los Alamitos California, United States, 90720Downtown LA Research | Los Angeles California, United States, 90017Clinical Research Institute | Los Angeles California, United States, 90048WR-PRI | Newport Beach California, United States, 92660Hillcrest Medical Research | DeLand Florida, United States, 32720MD Clinical | Hallandale Florida, United States, 33009Multi-Specialty Research Associates | Lake City Florida, United States, 32055ClinCloud | Maitland Florida, United States, 32751Biotech Pharmaceuticals | Miami Florida, United States, 33155Behavioral Clinical Research | Miami Lakes Florida, United States, 33061CNS Health Care - Orlando | Orlando Florida, United States, 32801Complete Health Research | Ormond Beach Florida, United States, 32174Infinity Clinical Research | Sunrise Florida, United States, 33351Santos Research Center, Corp | Tampa Florida, United States, 33615Palm Beach Research Center | West Palm Beach Florida, United States, 33409Clinical Research CF | Winter Haven Florida, United States, 33880Advanced Clinical Research | Meridian Idaho, United States, 83642Integrated Clinical Trial Services, Inc | West Des Moines Iowa, United States, 50265Delricht Research | Prairieville Louisiana, United States, 70769Medvadis Research at Boston PainCare Center | Waltham Massachusetts, United States, 02451Healthcare Research Network | Hazelwood Missouri, United States, 63042Clinvest Research | Springfield Missouri, United States, 65810Montana Medical Research | Missoula Montana, United States, 59808Wake Research - Clinical Research Center of Nevada | Las Vegas Nevada, United States, 89118Dartmouth-Hitchcock Neurology Headache Clinic | Lebanon New Hampshire, United States, 03766Hassman Research Institute | Berlin New Jersey, United States, 08009Albuquerque Clinical Trials | Albuquerque New Mexico, United States, 87102SPRI Clinical Research | Brooklyn New York, United States, 11235Montefiore Medical Center | The Bronx New York, United States, 10461PharmQuest | Greensboro North Carolina, United States, 27408PMG Research of Wilmington | Wilmington North Carolina, United States, 28401CTI Clinical Research Center | Cincinnati Ohio, United States, 45212Rapid Medical Research | Cleveland Ohio, United States, 44122Neurology Diagnosis | Dayton Ohio, United States, 45459Delricht Research | Tulsa Oklahoma, United States, 74133Thomas Jefferson University/Jefferson Headache Center | Philadelphia Pennsylvania, United States, 19107Omega Medical Research | Warwick Rhode Island, United States, 02886CNS Healthcare - Memphis | Memphis Tennessee, United States, 38119FutureSearch Trials of Neurology | Austin Texas, United States, 78731DM Clinical Research | Tomball Texas, United States, 77375Charlottesville Medical Research | Charlottesville Virginia, United States, 22911Georgetown University Hospital, Department of Neurology | McLean Virginia, United States, 22101
Investigators
Study Chair: Detlef Albrecht, MD, Satsuma Pharmaceuticals, Inc.
Study Documents (Full Text)
Documents provided by Satsuma Pharmaceuticals, Inc.: Study Protocol  November 23, 2021Documents provided by Satsuma Pharmaceuticals, Inc.: Statistical Analysis Plan  September 18, 2022