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

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine, Migraine With Aura, Migraine Without Aura

In brief

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

Key facts

Study ID

NCT03901482

Run by

Satsuma Pharmaceuticals, Inc.

People needed

1201

Starts

2019-06-24

Expected to finish

2020-08-13

Last updated by the study team

2023-06-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Alabama Clinical Therapeutics — Birmingham, Alabama, United States
• Alea Research — Phoenix, Arizona, United States
• Elite Clinical Studies — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Tucson Neuroscience Research — Tucson, Arizona, United States
• The Research Center of Southern California — Carlsbad, California, United States
• Med Center Medical Clinic — Carmichael, California, United States
• WR-PRI — Encino, California, United States
• Marvel Clinical Research — Huntington Beach, California, United States
• eStudySite — La Mesa, California, United States
• Collaborative Neuroscience — Long Beach, California, United States
• WP-PRI — Los Alamitos, California, United States
• Downtown LA Research — Los Angeles, California, United States
• Cal Neuro Research Group — Los Angeles, California, United States
• WR-PRI — Newport Beach, California, United States
• Alliance Sites — Oakland, California, United States
• Stanford Neuroscience Health Center — Palo Alto, California, United States
• National Research Institute — Panorama City, California, United States
• Empire Clinical Reserch — Pomona, California, United States
• Artemis Institute for Clinical Research- Riverside — Riverside, California, United States
• Artemis Institute of Clinical Research - San Diego — San Diego, California, United States
• Pacific Research Network — San Diego, California, United States
• WR-MCCR — San Diego, California, United States
• Optimus Medical Group — San Francisco, California, United States
• Accel Clinical - Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.