Loading clinical trials...

A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

An Open-Label, 12-Month Study to Evaluate the Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine

NCT04406649•Satsuma Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (44)

WR-PRI

Encino, California, United States

Collaborative Neuroscience

Long Beach, California, United States

WR-PRI

Los Alamitos, California, United States

Downtown LA Research

Los Angeles, California, United States

Clinical Research Institute

Los Angeles, California, United States

WR-PRI

Newport Beach, California, United States

Hillcrest Medical Research

DeLand, Florida, United States

MD Clinical

Hallandale, Florida, United States

Multi-Specialty Research Associates

Lake City, Florida, United States

ClinCloud

Maitland, Florida, United States

Key Dates

Start Date

September 14, 2020

Primary Completion Date

January 16, 2023

Completion Date

January 16, 2023

Last Updated

July 3, 2023

Enrollment

482

ACTUAL participants

Conditions

MigraineMigraine With AuraMigraine Without Aura

Interventions

Dihydroergotamine

DRUG

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

NCT06641466

Menstrual Migraine

View study

RECRUITINGPHASE3

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

NCT07018713

Chronic Migraine

View study

RECRUITINGNA

Mind Body Balance for Pediatric Migraine

NCT04715685

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.