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

  • STATUS
    Recruiting
  • End date
    Oct 9, 2022
  • participants needed
    1400
  • sponsor
    Satsuma Pharmaceuticals, Inc.
Updated on 9 November 2021
headache
acute treatment
dihydroergotamine

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.

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).

Details
Condition Migraine (Adult), Migraine (Pediatric), migraines, Common Migraine, Migraine and Cluster Headaches, Primary Stabbing Headache, migraine aura, Migraine, Migraine with Aura
Treatment Placebo, Dihydroergotamine
Clinical Study IdentifierNCT04940390
SponsorSatsuma Pharmaceuticals, Inc.
Last Modified on9 November 2021

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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