At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 165 enrolled
Drug / intervention
TNX-201 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating TNX-201 and Placebo for Tension-Type Headache. Completed, enrolled 165 participants across 10 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTension-Type Headache
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartJun 2015
Primary CompletionFeb 2016
TodayJul 2026
First PostedApr 22, 2015
Enrollment StartJun 1, 2015
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.2 years ago
Interventions
TNX-201drug
TNX-201 capsule
Placebodrug
Placebo capsule