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Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache

NCT02423408 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2017-04-11

Study results available
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Summary

This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of a single dose of TNX-201 (140 mg) for the treatment of a single qualifying Tension-Type-Headache (TTH).

Conditions

  • Tension-Type Headache

Interventions

DRUG

TNX-201

TNX-201 capsule

DRUG

Placebo

Placebo capsule

Sponsors & Collaborators

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Tracie Ruther, M.S · 1 513 579 9911 ext 2214

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02423408 on ClinicalTrials.gov