EMERGE: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Single Doses of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine

Sponsors

Lead sponsor: Satsuma Pharmaceuticals, Inc.

Source Satsuma Pharmaceuticals, Inc.
Brief Summary

Study STS101-002 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine

Detailed Description

The EMERGE trial is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65 years).

Overall Status Active, not recruiting
Start Date June 24, 2019
Completion Date August 2020
Primary Completion Date June 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Pain Freedom at 2 Hours 2 Hours Post-Dose
Freedom From Most-Bothersome Symptom at 2 Hours 2 Hours Post-Dose
Secondary Outcome
Measure Time Frame
Sustained Pain-Free Up to 48 hours post-dosing
Rescue Medication Usage Up to 48 hours post-dosing
Pain Relapse Up to 48 hours post-dosing
Enrollment 1140
Condition
Intervention

Intervention type: Drug

Intervention name: Dihydroergotamine

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

Other name: Dihydroergotamine Mesylate

Intervention type: Drug

Intervention name: Placebos

Description: Placebo for STS101

Arm group label: STS101 Placebo

Other name: STS101 Placebo

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)

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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Detlef Albrecht, MD Study Chair Satsuma Pharmaceuticals, Inc.
Location
facility
Accel Clinical - Birmingham | Birmingham, Alabama, 35216, United States
Alabama Clinical Therapeutics | Birmingham, Alabama, 35235, United States
Alea Research | Phoenix, Arizona, 85012, United States
Elite Clinical Studies | Phoenix, Arizona, 85018, United States
Arizona Research Center | Phoenix, Arizona, 85053, United States
Tucson Neuroscience Research | Tucson, Arizona, 85710, United States
The Research Center of Southern California | Carlsbad, California, 92011, United States
Med Center Medical Clinic | Carmichael, California, 95608, United States
WR-PRI | Encino, California, 91316, United States
Marvel Clinical Research | Huntington Beach, California, 92647, United States
eStudySite | La Mesa, California, 91942, United States
Collaborative Neuroscience | Long Beach, California, 90806, United States
WP-PRI | Los Alamitos, California, 90720, United States
Downtown LA Research | Los Angeles, California, 90017, United States
Cal Neuro Research Group | Los Angeles, California, 90024, United States
WR-PRI | Newport Beach, California, 92660, United States
Alliance Sites | Oakland, California, 94607, United States
Stanford Neuroscience Health Center | Palo Alto, California, 94304, United States
National Research Institute | Panorama City, California, 91402, United States
Empire Clinical Reserch | Pomona, California, 91767, United States
Artemis Institute for Clinical Research- Riverside | Riverside, California, 92503, United States
Artemis Institute of Clinical Research - San Diego | San Diego, California, 92103, United States
Pacific Research Network | San Diego, California, 92103, United States
WR-MCCR | San Diego, California, 92108, United States
Optimus Medical Group | San Francisco, California, 94102, United States
Artemis Institute for Clinical Research- San Marcos | San Marcos, California, 92103, United States
Neurological Research Institute | Santa Monica, California, 90404, United States
Schuster Medical Research Institute | Sherman Oaks, California, 91403, United States
Southern California Research | Simi Valley, California, 93065, United States
Encompass Clinical Research | Spring Valley, California, 91978, United States
Hartford Headache Center | East Hartford, Connecticut, 06118, United States
CMR of Greater New Haven | Hamden, Connecticut, 06517, United States
New England Institute for Neurology and Headache | Stamford, Connecticut, 06905, United States
Chase Medical Research | Waterbury, Connecticut, 06708, United States
Accel Clinical - DeLand | DeLand, Florida, 32720, United States
Gulf Coast Clinical Research | Fort Myers, Florida, 33912, United States
MD Clinical | Hallandale Beach, Florida, 33009, United States
AGA Clinical Trials | Hialeah, Florida, 33012, United States
Galiz Research- Hialeah | Hialeah, Florida, 33016, United States
Research Centers of America | Hollywood, Florida, 33024, United States
CNS Healthcare | Jacksonville, Florida, 32256, United States
Multispecialty Research Associates | Lake City, Florida, 32055, United States
ClinCloud | Maitland, Florida, 32751, United States
Premier Clinical Reserch Institute, INC | Miami, Florida, 33122, United States
QPS MRA | Miami, Florida, 33143, United States
Applemed Research Group | Miami, Florida, 33155, United States
Biotech Pharmaceuticals Group | Miami, Florida, 33155, United States
Behavioral Clinical Research | North Miami, Florida, 33161, United States
Sensible Health | Ocoee, Florida, 34761, United States
Accel - Orange City | Orange City, Florida, 32763, United States
CNS Health Care - Orlando | Orlando, Florida, 32801, United States
Neurology Associates of Ormond Beach | Ormond Beach, Florida, 32174, United States
Infinity Clinical Research, LLC | Sunrise, Florida, 33351, United States
Precision Clinical Research | Sunrise, Florida, 33351, United States
Clinical Research CF | Winter Haven, Florida, 33880, United States
Conquest Research | Winter Park, Florida, 32789, United States
Neuro Studios | Decatur, Georgia, 30033, United States
Advanced Clinical Research | Meridian, Idaho, 83642, United States
PMG Research of DuPage Medical Group | Downers Grove, Illinois, 60515, United States
Healthcare Research Network II, LLC | Flossmoor, Illinois, 60422, United States
Phoenix Medical Reserch | Prairie Village, Kansas, 66208, United States
Delricht - Baton Rouge | Baton Rouge, Louisiana, 70816, United States
Tandem Clinical Research | Marrero, Louisiana, 70072, United States
Delricht - NewOrleans | New Orleans, Louisiana, 70124, United States
Boston Clinical Trials | Boston, Massachusetts, 02131, United States
BTC of New Bedford | New Bedford, Massachusetts, 02740, United States
Medvadis Research Group | Watertown, Massachusetts, 02472, United States
Michigan Headache and Neurological Institute | Ann Arbor, Michigan, 48104, United States
Michigan Pain Consultants | Wyoming, Michigan, 49519, United States
Minneapolis Clinic of Neurology | Burnsville, Minnesota, 55337, United States
Healthcare Research Network II, LLC | Hazelwood, Missouri, 63042, United States
StudyMetrix Research | Saint Peters, Missouri, 63303, United States
Clinvest Research | Springfield, Missouri, 65810, United States
Montana Medical Research | Missoula, Montana, 59808, United States
Quality Clinical Research | Omaha, Nebraska, 68114, United States
Altea Research | Las Vegas, Nevada, 89102, United States
Wake Research-Clinical Research Center of Nevada | Las Vegas, Nevada, 89118, United States
Clinical Research of South Nevada | Las Vegas, Nevada, 89121, United States
Dartmouth-Hitchcock Clinical Trials Office | Lebanon, New Hampshire, 03756, United States
Hassman Research Institute | Berlin, New Jersey, 08009, United States
Albuquerque Clinical Trials | Albuquerque, New Mexico, 87109, United States
Albuquerque Neuroscience | Albuquerque, New Mexico, 87109, United States
Montefiori Medical Center | Bronx, New York, 10461, United States
SPRI Clinical Trials | Brooklyn, New York, 11235, United States
Manhattan Behavioral Medicine | New York, New York, 10036, United States
Rochester Clinical Research | Rochester, New York, 14609, United States
Upstate Clinical Research Associates | Williamsville, New York, 14221, United States
Headache Wellness Center - Greensboro | Greensboro, North Carolina, 27405, United States
PharmQuest | Greensboro, North Carolina, 27408, United States
M3-Wake Research | Raleigh, North Carolina, 27612, United States
PMG Research of Wilmington | Wilmington, North Carolina, 28401, United States
Lillestol Research | Fargo, North Dakota, 58104, United States
CTI Clinical Research Center | Cincinnati, Ohio, 45212, United States
Rapid Medical Research Inc. | Cleveland, Ohio, 44122, United States
Aventiv Research | Columbus, Ohio, 43213, United States
Neurology Diagnosis | Dayton, Ohio, 45459, United States
Delynn Institute | Oklahoma City, Oklahoma, 73112, United States
Delricht Research | Tulsa, Oklahoma, 74133, United States
Thomas Jefferson University/Jefferson Headache Center | Philadelphia, Pennsylvania, 19107, United States
CNS Research Inc - Rhode Island | Rumford, Rhode Island, 02916, United States
Omega Medical Research | Warwick, Rhode Island, 02886, United States
WR-ClinSearch | Chattanooga, Tennessee, 37421, United States
CNS Healthcare | Memphis, Tennessee, 38119, United States
Clinical Research Associates | Nashville, Tennessee, 37203, United States
Nashville Neuroscience Group | Nashville, Tennessee, 37203, United States
Wellness Clinical Research | Allen, Texas, 75013, United States
FutureSearch Trials of Neurology | Austin, Texas, 78731, United States
Future Search Trials | Dallas, Texas, 75231, United States
HRMD Research | Dallas, Texas, 75240, United States
Texas Center for Drug Development | Houston, Texas, 77081, United States
SMS Clinical Research | Mesquite, Texas, 75149, United States
DM Clinical Research | Tomball, Texas, 77375, United States
ClinPoint Trials | Waxahachie, Texas, 75165, United States
Aspen Clinical Research | Orem, Utah, 84058, United States
Wasatch Clinical Research | Salt Lake City, Utah, 84107, United States
Highland Clinical Research | Salt Lake City, Utah, 84124, United States
Charlottesville Medical Research | Charlottesville, Virginia, 22911, United States
Location Countries

United States

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: STS101 Low Dose

Arm group type: Experimental

Description: STS101 (dihydroergotamine nasal powder), low dose

Arm group label: STS101 High Dose

Arm group type: Experimental

Description: STS101 (dihydroergotamine nasal powder), high dose

Arm group label: STS101 Placebo

Arm group type: Placebo Comparator

Description: STS101 Placebo

Acronym EMERGE
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov