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

Primary Purpose

Migraine, Migraine With Aura, Migraine Without Aura

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dihydroergotamine
Placebos
Sponsored by
Satsuma Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring dihydroergotamine, dihydroergotamine mesylate, migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Accel Clinical - Birmingham
  • Alabama Clinical Therapeutics
  • Alea Research
  • Elite Clinical Studies
  • Arizona Research Center
  • Tucson Neuroscience Research
  • The Research Center of Southern California
  • Med Center Medical Clinic
  • WR-PRI
  • Marvel Clinical Research
  • eStudySite
  • Collaborative Neuroscience
  • WP-PRI
  • Downtown LA Research
  • Cal Neuro Research Group
  • WR-PRI
  • Alliance Sites
  • Stanford Neuroscience Health Center
  • National Research Institute
  • Empire Clinical Reserch
  • Artemis Institute for Clinical Research- Riverside
  • Artemis Institute of Clinical Research - San Diego
  • Pacific Research Network
  • WR-MCCR
  • Optimus Medical Group
  • Artemis Institute for Clinical Research- San Marcos
  • Neurological Research Institute
  • Schuster Medical Research Institute
  • Southern California Research
  • Encompass Clinical Research
  • Hartford Headache Center
  • CMR of Greater New Haven
  • New England Institute for Neurology and Headache
  • Chase Medical Research
  • Accel Clinical - DeLand
  • Gulf Coast Clinical Research
  • MD Clinical
  • AGA Clinical Trials
  • Galiz Research- Hialeah
  • Research Centers of America
  • CNS Healthcare
  • Multispecialty Research Associates
  • ClinCloud
  • Premier Clinical Reserch Institute, INC
  • QPS MRA
  • Applemed Research Group
  • Biotech Pharmaceuticals Group
  • Behavioral Clinical Research
  • Sensible Health
  • Accel - Orange City
  • CNS Health Care - Orlando
  • Neurology Associates of Ormond Beach
  • Infinity Clinical Research, LLC
  • Precision Clinical Research
  • Clinical Research CF
  • Conquest Research
  • Neuro Studios
  • Advanced Clinical Research
  • PMG Research of DuPage Medical Group
  • Healthcare Research Network II, LLC
  • Phoenix Medical Reserch
  • Delricht - Baton Rouge
  • Tandem Clinical Research
  • Delricht - NewOrleans
  • Boston Clinical Trials
  • BTC of New Bedford
  • Medvadis Research Group
  • Michigan Headache and Neurological Institute
  • Michigan Pain Consultants
  • Minneapolis Clinic of Neurology
  • Healthcare Research Network II, LLC
  • StudyMetrix Research
  • Clinvest Research
  • Montana Medical Research
  • Quality Clinical Research
  • Altea Research
  • Wake Research-Clinical Research Center of Nevada
  • Clinical Research of South Nevada
  • Dartmouth-Hitchcock Clinical Trials Office
  • Hassman Research Institute
  • Albuquerque Clinical Trials
  • Albuquerque Neuroscience
  • Montefiori Medical Center
  • SPRI Clinical Trials
  • Manhattan Behavioral Medicine
  • Rochester Clinical Research
  • Upstate Clinical Research Associates
  • Headache Wellness Center - Greensboro
  • PharmQuest
  • M3-Wake Research
  • PMG Research of Wilmington
  • Lillestol Research
  • CTI Clinical Research Center
  • Rapid Medical Research Inc.
  • Aventiv Research
  • Neurology Diagnosis
  • Delynn Institute
  • Delricht Research
  • Thomas Jefferson University/Jefferson Headache Center
  • CNS Research Inc - Rhode Island
  • Omega Medical Research
  • WR-ClinSearch
  • CNS Healthcare
  • Clinical Research Associates
  • Nashville Neuroscience Group
  • Wellness Clinical Research
  • FutureSearch Trials of Neurology
  • Future Search Trials
  • HRMD Research
  • Texas Center for Drug Development
  • SMS Clinical Research
  • DM Clinical Research
  • ClinPoint Trials
  • Aspen Clinical Research
  • Wasatch Clinical Research
  • Highland Clinical Research
  • Charlottesville Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

STS101 Low Dose

STS101 High Dose

STS101 Placebo

Arm Description

STS101 (dihydroergotamine nasal powder), low dose

STS101 (dihydroergotamine nasal powder), high dose

STS101 Placebo

Outcomes

Primary Outcome Measures

Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose
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).
Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose
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.

Secondary Outcome Measures

Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose
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 relief means the pain went from moderate (2) or severe (3) to mild pain (1) or no pain (0).

Full Information

First Posted
April 2, 2019
Last Updated
June 9, 2023
Sponsor
Satsuma Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03901482
Brief Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine
Acronym
EMERGE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
August 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Satsuma Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Migraine With Aura, Migraine Without Aura
Keywords
dihydroergotamine, dihydroergotamine mesylate, migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STS101 Low Dose
Arm Type
Experimental
Arm Description
STS101 (dihydroergotamine nasal powder), low dose
Arm Title
STS101 High Dose
Arm Type
Experimental
Arm Description
STS101 (dihydroergotamine nasal powder), high dose
Arm Title
STS101 Placebo
Arm Type
Placebo Comparator
Arm Description
STS101 Placebo
Intervention Type
Drug
Intervention Name(s)
Dihydroergotamine
Other Intervention Name(s)
Dihydroergotamine Mesylate
Intervention Description
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
STS101 Placebo
Intervention Description
Placebo for STS101
Primary Outcome Measure Information:
Title
Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose
Description
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).
Time Frame
2 Hours Post-Dose
Title
Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose
Description
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.
Time Frame
2 Hours Post-Dose
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose
Description
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 relief means the pain went from moderate (2) or severe (3) to mild pain (1) or no pain (0).
Time Frame
2 Hours Post Dose

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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