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

NCT04406649 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2023-07-03

Study results available
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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.

Conditions

  • Migraine
  • Migraine With Aura
  • Migraine Without Aura

Interventions

DRUG

Dihydroergotamine

Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

Sponsors & Collaborators

  • Satsuma Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Detlef Albrecht, MD · Satsuma Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2023-01-16
Completion
2023-01-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04406649 on ClinicalTrials.gov