An Open-Label, 12-Month Study to Evaluate the Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine
Who is this study for? Patients with migraine
What treatments are being studied? Dihydroergotamine
Status: Completed
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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)
Locations
United States
California
WR-PRI
Encino
Collaborative Neuroscience
Long Beach
WR-PRI
Los Alamitos
Clinical Research Institute
Los Angeles
Downtown LA Research
Los Angeles
WR-PRI
Newport Beach
Florida
Hillcrest Medical Research
Deland
MD Clinical
Hallandale
Multi-Specialty Research Associates
Lake City
ClinCloud
Maitland
Biotech Pharmaceuticals
Miami
Behavioral Clinical Research
Miami Lakes
CNS Health Care - Orlando
Orlando
Complete Health Research
Ormond Beach
Infinity Clinical Research
Sunrise
Santos Research Center, Corp
Tampa
Palm Beach Research Center
West Palm Beach
Clinical Research CF
Winter Haven
Iowa
Integrated Clinical Trial Services, Inc
West Des Moines
Idaho
Advanced Clinical Research
Meridian
Louisiana
Delricht Research
Prairieville
Massachusetts
Medvadis Research at Boston PainCare Center
Waltham
Missouri
Healthcare Research Network
Hazelwood
Clinvest Research
Springfield
Montana
Montana Medical Research
Missoula
North Carolina
PharmQuest
Greensboro
PMG Research of Wilmington
Wilmington
New Hampshire
Dartmouth-Hitchcock Neurology Headache Clinic
Lebanon
New Jersey
Hassman Research Institute
Berlin
New Mexico
Albuquerque Clinical Trials
Albuquerque
Nevada
Wake Research - Clinical Research Center of Nevada
Las Vegas
New York
SPRI Clinical Research
Brooklyn
Montefiore Medical Center
The Bronx
Ohio
CTI Clinical Research Center
Cincinnati
Rapid Medical Research
Cleveland
Neurology Diagnosis
Dayton
Oklahoma
Delricht Research
Tulsa
Pennsylvania
Thomas Jefferson University/Jefferson Headache Center
Philadelphia
Rhode Island
Omega Medical Research
Warwick
Tennessee
CNS Healthcare - Memphis
Memphis
Texas
FutureSearch Trials of Neurology
Austin
DM Clinical Research
Tomball
Virginia
Charlottesville Medical Research
Charlottesville
Georgetown University Hospital, Department of Neurology
Mclean
Time Frame
Start Date: 2020-09-14
Completion Date: 2023-01-16
Participants
Target number of participants: 482
Treatments
Experimental: STS101
STS101 (dihydroergotamine nasal powder)
Authors
Davi DiBenedetto, Robert Molpus, Clancy Cone, David Carpenter, James Maynard, John Hudson, Lora McGill, Toby Briskin, Malisa Agard, Beth Safirstein, Jessica Ailani, Taylor Sanders, Kathleen Gannon, Mira Baron, Richard Lipton, Olga Lapeyra, Esteban Olivera, Enrique De La Torre, Daniel Grosz, John Hill, David Rosenberg, Salil Nadkarni, Mesha Chadwick, David DiBenedetto, Guy Strauss, Lawrence Allen, Michael Hassman, Melita Tate, Alexander Murray, Nader Oskooilar, Joel Vandersluis, James Clark, Larry Reed, Barbara Nye, Muhammad Irfan, David Kudrow, Robinson Koilpillai, Nirav Patel, William Young
Related Therapeutic Areas
Sponsors
Leads: Satsuma Pharmaceuticals, Inc.