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

Phase 3

Completed

Conditions: Migraine
Migraine With Aura
Migraine Without Aura

Interventions: Drug: Dihydroergotamine

Registration Number: NCT04406649

Lead Sponsor: Satsuma Pharmaceuticals, Inc.

Brief 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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 482

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STS101	Dihydroergotamine	STS101 (dihydroergotamine nasal powder)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)	At Month 12 of Study Medication Dosing	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 Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)	At Month 12 of Study Drug Administration	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

Name	Time	Method

Trial Locations

Locations (41): WR-PRI
🇺🇸
Newport Beach, California, United States
Collaborative Neuroscience
🇺🇸
Long Beach, California, United States
Downtown LA Research
🇺🇸
Los Angeles, California, United States
Clinical Research Institute
🇺🇸
Los Angeles, California, United States
Hillcrest Medical Research
🇺🇸
DeLand, Florida, United States
MD Clinical
🇺🇸
Hallandale Beach, Florida, United States
Multi-Specialty Research Associates
🇺🇸
Lake City, Florida, United States
ClinCloud
🇺🇸
Maitland, Florida, United States
Behavioral Clinical Research
🇺🇸
Miami Lakes, Florida, United States
Biotech Pharmaceuticals
🇺🇸
Miami, Florida, United States
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WR-PRI
🇺🇸Newport Beach, California, United States