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SUMMIT: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine

Sponsor
Satsuma Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04940390
Collaborator
(none)
1,400
Enrollment
140
Locations
2
Arms
15
Anticipated Duration (Months)
10
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study STS101-007 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Study STS101-007 is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65 years).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine
Actual Study Start Date :
Jun 30, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: STS101

STS101 (dihydroergotamine nasal powder)

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

    		•
    Experimental: STS101 Placebo

    STS101 Placebo

    Drug: Placebo
    Placebo for STS101
    Other Names:
  • STS101 Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain Freedom at 2 Hours [2 Hours Post-Dose]

      Proportion of subjects free from headache pain at 2 hours post dose

    2. Freedom From Most-Bothersome Symptom at 2 Hours [2 Hours Post-Dose]

      Proportion of subjects free from most bothersome symptom (MBS) among photophobia, phonophobia and nausea at 2 hours post dose

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Central Trials Birmingham Alabama United States 35205
    2 MD First Research Chandler Arizona United States 85286
    3 Elite Clinical Studies Phoenix Arizona United States 85018
    4 Alliance For Multispecialty Research Tempe Arizona United States 85283
    5 Cognitive Clinical Trials, LLC Tempe Arizona United States 85283
    6 Clinedge, LLC Tucson Arizona United States 85704
    7 ERG Clinical Little Rock Arkansas United States 72211
    8 Atria Clinical Research North Little Rock Arkansas United States 72117
    9 Hope Clinical Research Canoga Park California United States 91303
    10 Wr-Pri, Llc Encino California United States 91316
    11 Neuro-Pain Medical Center Ince Fresno California United States 93710
    12 Neurology Center of North Orange County Fullerton California United States 92835
    13 Estudy Site - La Mesa La Mesa California United States 91942
    14 Wr-Pri Llc Los Alamitos California United States 90720
    15 Downtown LA Research Center Los Angeles California United States 90017
    16 Clinical Research Institute Los Angeles California United States 90048
    17 Wr-Pri Llc Newport Beach California United States 92660
    18 Artemis Institute for Clinical Research - Riverside Riverside California United States 92503
    19 Artemis Institute for Clinical Research - San Diego San Diego California United States 92103
    20 WR-MCCR San Diego California United States 92108
    21 Acclaim Clinical Research San Diego California United States 92120
    22 National Research Institute, A Clinical Research Organization Santa Ana California United States 92704
    23 Alpine Clinical Research Center, Inc Boulder Colorado United States 80301
    24 Clinedge, LLC Cromwell Connecticut United States 06416
    25 Neurology Offices of South Florida Boca Raton Florida United States 33428
    26 Velocity Clinical Research, Hallendale Beach Hallandale Beach Florida United States 33009
    27 Infinity Clinical Research, LLC Hollywood Florida United States 33024
    28 Elite Research Network, LLC a Florida LLC Jacksonville Florida United States 32216
    29 Clinical Neuroscience Solutions, Inc Jacksonville Florida United States 32256
    30 Elite Research Network LLC a Florida LLC Jupiter Florida United States 33458
    31 Advanced Research Institute of Miami Kissimmee Florida United States 34741
    32 Multi-Specialty Research Associates Lake City Florida United States 32055
    33 Clinicloud Maitland Florida United States 32751
    34 Next Phase Research Miami Florida United States 33144
    35 Applemed Research Group Miami Florida United States 33155
    36 Biotech Pharmaceuticals Group LLC Miami Florida United States 33155
    37 Novel Clinical Research Center LLC Miami Florida United States 33173
    38 Floridian Research Miami Florida United States 33179
    39 Behavioral Clinical Research North Miami Florida United States 33161
    40 Accel-Orange City Orange City Florida United States 32763
    41 CNS Health Care Orlando Orlando Florida United States 32801
    42 Complete Health Research Ormond Beach Florida United States 32174
    43 Oveido Medical Research Oviedo Florida United States 32765
    44 Santos Research Center Tampa Florida United States 33603
    45 VICIS Clinical Research, Inc Tampa Florida United States 33615
    46 Palm Beach Research West Palm Beach Florida United States 33409
    47 Conquest Research, LLC Winter Park Florida United States 32789
    48 Delricht Atlanta Georgia United States 30329
    49 I-Research Atlanta Decatur Georgia United States 30030
    50 Alpha Clinical Research Georgia Johns Creek Georgia United States 30022
    51 Clin-Edge, LLC Marietta Georgia United States 30060
    52 I Research Savannah Savannah Georgia United States 31405
    53 Advanced Clinical Research Meridian Idaho United States 83642
    54 Great Lakes Clinical Trials Chicago Illinois United States 60640
    55 CIS Research Wauconda Illinois United States 60084
    56 Medisphere Medical Research Center Evansville Indiana United States 47714
    57 PMG Research Inc Ames Iowa United States 50010
    58 Meridian Clinical Research Sioux City Iowa United States 51106
    59 Integrated Clinical Trial SVC West Des Moines Iowa United States 50265
    60 Otrimed Clinical Research Edgewood Kentucky United States 41017
    61 Alliance For Multispecialty Research Lexington Kentucky United States 40509
    62 Louisville Metabolic & Atherosclerosis Research Center Louisville Kentucky United States 40213
    63 Delricht Research Baton Rouge Louisiana United States 70817
    64 Crescent City Headache and Neurology Chalmette Louisiana United States 70043
    65 Delricht Covington Louisiana United States 70433
    66 Alliance for Multispecialty Research New Orleans Louisiana United States 70119
    67 Delricht-New Orleans New Orleans Louisiana United States 70124
    68 Boston Clinical Trials Boston Massachusetts United States 02131
    69 BTC of New Bedford New Bedford Massachusetts United States 02740
    70 Northeast Medical Research Associates North Dartmouth Massachusetts United States 02747
    71 "Medvadis Research Corp, Llc @Boston Paincare Center " Waltham Massachusetts United States 02451
    72 MHNI Ann Arbor Michigan United States 48104
    73 Minneapolis Clinic of Neurology Burnsville Minnesota United States 55337
    74 Delricht Gulfport Mississippi United States 39503
    75 Alliance for Multispecialty Research Kansas City Missouri United States 64114
    76 Montana Medical Research, Inc Missoula Montana United States 59808
    77 Skyline Medical Center, PC CCT Research Elkhorn Nebraska United States 68022
    78 Cognitive Clinical Trials, LLC Fremont Nebraska United States 68025
    79 Quality Clinical Research, Inc Omaha Nebraska United States 68114
    80 Excel Clinical Research Las Vegas Nevada United States 89109
    81 Wake Research-Clinical Research Center of Nevada LLC Las Vegas Nevada United States 89118
    82 Clinedge LLC North Las Vegas Nevada United States 89030
    83 Albuquerque Clinical Trials Albuquerque New Mexico United States 87102
    84 Integrative Clinical Trials Brooklyn New York United States 11229
    85 SPRI Clinical Trials, LLC Brooklyn New York United States 11235
    86 North Suffolk Neurology Commack New York United States 11725
    87 Drug Trials America Hartsdale New York United States 10530
    88 Central New York Clinical Research Manlius New York United States 13104
    89 Upstate Clinical Research Associates Williamsville New York United States 14221
    90 PMG Research of Charlotte Charlotte North Carolina United States 28209
    91 Onsite Clinical Charlotte North Carolina United States 28277
    92 Headache Wellness Center - Greensboro Greensboro North Carolina United States 27405
    93 Pharmquest, LLC Greensboro North Carolina United States 27408
    94 Peters Medical Research High Point North Carolina United States 27262
    95 North Carolina Clinical Research Raleigh North Carolina United States 27607
    96 PMG Research, Inc Raleigh North Carolina United States 27609
    97 PMG Research of Wilmington, LLC Wilmington North Carolina United States 28401
    98 PMG Research Inc Winston-Salem North Carolina United States 27103
    99 Plains Clinical Research South West Fargo North Dakota United States 58104
    100 CTI Clinical Research Center Cincinnati Ohio United States 45212
    101 Aventiv Research Columbus Ohio United States 43213
    102 Daytona Clinical Dayton Ohio United States 45406
    103 Aventiv Research, Inc Dublin Ohio United States 43016
    104 OK Clinical Research Edmond Oklahoma United States 73034
    105 Intend Research Norman Oklahoma United States 73069
    106 Elite Research Network, LLC a Florida LLC Norman Oklahoma United States 73072
    107 Hightower Clinical Oklahoma City Oklahoma United States 73134
    108 Delricht Research Tulsa Oklahoma United States 74133
    109 Tekton Research Yukon Oklahoma United States 73099
    110 Suburban Research Associates Media Pennsylvania United States 19063
    111 Ocean State Clinical Research Partners Lincoln Rhode Island United States 02865
    112 Velocity Clinical Research.- Providence Warwick Rhode Island United States 02886
    113 Clinedge LLC - Clinical Trials SSC Charleston South Carolina United States 29406
    114 Tribe CR Greenville South Carolina United States 29607
    115 Coastal Carolina Research Center Inc North Charleston South Carolina United States 29405
    116 Hillcrest Clinical Research Simpsonville South Carolina United States 29681
    117 Internal Medicine and Pediatric Associates of Bristol, PC Bristol Tennessee United States 37620
    118 New Phase Research & Development Knoxville Tennessee United States 37909
    119 Clinical Research Associates, Inc Nashville Tennessee United States 37203
    120 Future Search Trials of Neurology Austin Texas United States 78731
    121 Premier Family Physicians Austin Texas United States 78735
    122 Discoveresearch Bryan Texas United States 77802
    123 Gill Neurosciences Cypress Texas United States 77429
    124 Future Search Trials of Dallas, LP Dallas Texas United States 75231
    125 Cedar Health Research, LLC Dallas Texas United States 75251
    126 Ventavia Research Fort Worth Texas United States 76104
    127 North Texas Institute of Neurology Frisco Texas United States 75034
    128 Epic Clinical Research Lewisville Texas United States 75057
    129 DM Clinical Research Magnolia Texas United States 77355
    130 Village Health Partners Plano Texas United States 75024
    131 Sun Research San Antonio Texas United States 78215
    132 VIP Trials San Antonio Texas United States 78230
    133 DM Clinical Research Tomball Texas United States 77375
    134 Advanced Research Institute Ogden Utah United States 84405
    135 Aspen Clinical Research, LLC Orem Utah United States 84058
    136 Charlottesville Medical Research Charlottesville Virginia United States 22911
    137 Alliance For Multispecialty Research Norfolk Virginia United States 23502
    138 Tidewater Integrated Medical Research Virginia Beach Virginia United States 23454
    139 Northwest Clinical Research Center Bellevue Washington United States 98007
    140 Seattle Womens Seattle Washington United States 98105

    Sponsors and Collaborators

    • Satsuma Pharmaceuticals, Inc.

    Investigators

    • Study Chair: Detlef Albrecht, MD, Satsuma Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Satsuma Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT04940390
    Other Study ID Numbers:
    • STS101-007
    First Posted:
    Jun 25, 2021
    Last Update Posted:
    Apr 22, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Satsuma Pharmaceuticals, Inc.
    dihydroergotamine
    dihydroergotamine mesylate
    migraine
    Additional relevant MeSH terms:
    Migraine Disorders
    Migraine without Aura
    Migraine with Aura
    Dihydroergotamine

    Study Results

    No Results Posted as of Apr 22, 2022