NCT02423408

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

A Proof-of-Concept Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-201 for the Treatment of A Single Tension-Type Headache

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study will be conducted in 4 periods (the Screening Period, the Run-In Period, the Double-Blind Treatment Period and the Follow-up Period) and 4 visits (the Screening Visit, Enrollment Visit, Randomization Visit and End-of-Study Visit). Screening Period- Eligible subjects who provide written informed consent to participate will have study assessments performed at the Screening. Run-In Period- The Run-In Period will last for at least 28 days. During the Run-In period, subjects will be assessed for frequency of headache, study compliance and to ensure they meet all required study criteria for randomization. Double-Blind Treatment Period- The Double-Blind Treatment Period (Treatment Period) will last up to 4 weeks or until a qualifying headache episode has occurred and been treated using the study drug, whichever occurs first. Follow-up Period- All subjects will return to the investigational site for this visit, regardless of whether they have treated a qualifying TTH with study medication. Subjects who have not treated a qualifying TTH with study drug during the Treatment Period will be asked to return study materials and undergo safety evaluations at the End-of-Study Visit and will be discharged from the study. Subjects who have treated a qualifying TTH with study drug during the Treatment Period will ingest a 140 mg dose of open-label TNX-201 at this visit and undergo urine and blood sample collection for 3 hours post-dose to characterize each subject's genetic metabolism and PK profile.

Conditions

• Tension-Type Headache

Interventions

Type	Name	Description
DRUG	TNX-201	TNX-201 capsule
DRUG	Placebo	Placebo capsule

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-04-22
• Last updated: 2017-04-11
• Results posted: 2017-02-17

Locations

10 sites across 1 country: United States