Clinical trial NCT04406649: A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine
Official title: An 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Migraine With Aura
Migraine Without Aura
Keywords: dihydroergotamine
dihydroergotamine mesylate
migraine
Lead sponsor: Satsuma Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-28
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)
timeFrame: At Month 12 of Study Medication Dosing
measure: Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)
timeFrame: At Month 12 of Study Drug Administration
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: WR-PRI
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience
state: California
city: Los Alamitos
country: United States
facility: WR-PRI
state: California
city: Los Angeles
country: United States
facility: Downtown LA Research
state: California
city: Los Angeles
country: United States
facility: Clinical Research Institute
state: California
city: Newport Beach
country: United States
facility: WR-PRI
state: California
city: DeLand
country: United States
facility: Hillcrest Medical Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates
state: Florida
city: Maitland
country: United States
facility: ClinCloud
state: Florida
city: Miami Lakes
country: United States
facility: Behavioral Clinical Research
state: Florida
city: Miami
country: United States
facility: Biotech Pharmaceuticals
state: Florida
city: Orlando
country: United States
facility: CNS Health Care - Orlando
state: Florida
city: Ormond Beach
country: United States
facility: Complete Health Research
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research
state: Florida
city: Tampa
country: United States
facility: Santos Research Center, Corp
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research CF
state: Florida
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc
state: Iowa
city: Prairieville
country: United States
facility: Delricht Research
state: Louisiana
city: Waltham
country: United States
facility: Medvadis Research at Boston PainCare Center
state: Massachusetts
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Las Vegas
country: United States
facility: Wake Research - Clinical Research Center of Nevada
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Neurology Headache Clinic
state: New Hampshire
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: SPRI Clinical Research
state: New York
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnosis
state: Ohio
city: Tulsa
country: United States
facility: Delricht Research
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson University/Jefferson Headache Center
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Memphis
country: United States
facility: CNS Healthcare - Memphis
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: McLean
country: United States
facility: Georgetown University Hospital, Department of Neurology
state: Virginia
Study officials:
affiliation: Satsuma Pharmaceuticals, Inc.
name: Detlef Albrecht, MD
role: STUDY_CHAIR
References: