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An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)

NCT02856802 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2021-03-30

Study results available
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Summary

A safety and efficacy study of DFN-02 (Sumatriptan Nasal Spray 10 mg), being conducted at multiple centers in the United States.

Conditions

  • Migraine Headaches

Interventions

DRUG

Sumatriptan 10 mg Nasal Spray

100 μL nasal spray once

OTHER

Sumatriptan Placebo Nasal Spray

100 μL nasal spray once

Sponsors & Collaborators

  • Upsher-Smith Laboratories

    lead INDUSTRY

Principal Investigators

  • Sagar Munjal, MD · Dr. Reddy's Laboratories, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-07-11
Primary Completion
2017-02-10
Completion
2017-02-10

Countries

  • United States

Study Locations

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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 NCT02856802 on ClinicalTrials.gov