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NCT02423408 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache
A Phase 2 study, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 165
- Enrollment target
NCT02423408: Completed Phase 2 study, sponsored by Tonix Pharmaceuticals.
NCT02423408 is a Phase 2 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 165 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02423408, a Phase 2 study, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 165 participants
- Enrollment target
Study 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).
Primary Outcome
Number of subjects pain free at 2 hours post-dose (Pain assessed by 4-point NRS, VAS, and binary yes/no question). 4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe; "pain-free" defined as score = 0. VAS: 0-100 scale, anchored by verbal anchors of No Pain (0) vs. Worst Imaginable Headache Pain (100). "Pain-free" was defined as a score \<= 5
Interventions
- DRUG Placebo
- DRUG TNX-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT02423408 record still lists
NCT02423408 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02423408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02423408 about?
NCT02423408 is a clinical study titled "Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache". 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).
What is the current status of trial NCT02423408?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2015-06. Estimated completion is 2016-02.
What interventions are being tested in trial NCT02423408?
The interventions under investigation include: Placebo (DRUG), TNX-201 (DRUG).
Who is sponsoring clinical trial NCT02423408?
This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02423408's enrollment target sits among peer trials
165 410th of 2000 higher than 1,588 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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