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

Migraine Clinical Trial

— ASCEND  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04406649
• Other study ID #: STS101-003
• Status: Completed
• Phase: Phase 3
• Start date: September 14, 2020
• Est. completion date: January 16, 2023

Study information

• Verified date: June 2023
• Source: Satsuma Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 482
• Est. completion date: January 16, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Migraine With Aura
• Migraine Without Aura

Intervention

Drug:
• Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Hassman Research Institute	Berlin	New Jersey
United States	Montefiore Medical Center	Bronx	New York
United States	SPRI Clinical Research	Brooklyn	New York
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Rapid Medical Research	Cleveland	Ohio
United States	Neurology Diagnosis	Dayton	Ohio
United States	Hillcrest Medical Research	DeLand	Florida
United States	WR-PRI	Encino	California
United States	PharmQuest	Greensboro	North Carolina
United States	MD Clinical	Hallandale Beach	Florida
United States	Healthcare Research Network	Hazelwood	Missouri
United States	Multi-Specialty Research Associates	Lake City	Florida
United States	Wake Research - Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Neurology Headache Clinic	Lebanon	New Hampshire
United States	Collaborative Neuroscience	Long Beach	California
United States	WR-PRI	Los Alamitos	California
United States	Clinical Research Institute	Los Angeles	California
United States	Downtown LA Research	Los Angeles	California
United States	ClinCloud	Maitland	Florida
United States	Georgetown University Hospital, Department of Neurology	McLean	Virginia
United States	CNS Healthcare - Memphis	Memphis	Tennessee
United States	Advanced Clinical Research	Meridian	Idaho
United States	Biotech Pharmaceuticals	Miami	Florida
United States	Behavioral Clinical Research	Miami Lakes	Florida
United States	Montana Medical Research	Missoula	Montana
United States	WR-PRI	Newport Beach	California
United States	CNS Health Care - Orlando	Orlando	Florida
United States	Complete Health Research	Ormond Beach	Florida
United States	Thomas Jefferson University/Jefferson Headache Center	Philadelphia	Pennsylvania
United States	Delricht Research	Prairieville	Louisiana
United States	Clinvest Research	Springfield	Missouri
United States	Infinity Clinical Research	Sunrise	Florida
United States	Santos Research Center, Corp	Tampa	Florida
United States	DM Clinical Research	Tomball	Texas
United States	Delricht Research	Tulsa	Oklahoma
United States	Medvadis Research at Boston PainCare Center	Waltham	Massachusetts
United States	Omega Medical Research	Warwick	Rhode Island
United States	Integrated Clinical Trial Services, Inc	West Des Moines	Iowa
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Clinical Research CF	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Satsuma Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At Month 12 of Study Medication Dosing
Primary	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.	At Month 12 of Study Drug Administration