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

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).

Timeline

Start

2015-06

Primary completion

2016-02

Completion

2016-02

Outcome

Missed primary endpoint

release “the data showed that TNX-201 did not demonstrate efficacy in patients with ETTH whether or not they had a history of migraine headaches.” tonixpharma.com ↗

release “Tonix has determined that the study did not achieve its primary efficacy endpoint” tonixpharma.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TNX-201	Small molecule	140 mg	—

Indications

No indication recorded.