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

NCT04940390 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1591

Last updated 2023-11-27

Study results available
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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.

Conditions

  • Migraine
  • Migraine With Aura
  • Migraine Without Aura

Interventions

DRUG

Dihydroergotamine

Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

DRUG

Placebo

Placebo for STS101

Sponsors & Collaborators

  • Satsuma Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Detlef Albrecht, MD · Satsuma Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2022-10-13
Completion
2022-10-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT04940390 on ClinicalTrials.gov