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NCT05273749 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia
A Phase 3 study, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 457
- Enrollment target
NCT05273749: Completed Phase 3 study, sponsored by Tonix Pharmaceuticals.
NCT05273749 is a Phase 3 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 457 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05273749, a Phase 3 study, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 457 participants
- Enrollment target
Study Summary
This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.
Primary Outcome
Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome.
Interventions
- DRUG Placebo SL Tablet
- DRUG TNX-102 SL Tablet, 5.6 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 457 participants |
| Start Date | 2022-04-06 |
| Est. Completion | 2023-11-14 |
| Phase | Phase 3 |
What the finished NCT05273749 record still lists
NCT05273749 is an interventional study that assigns participants to a tested intervention. The registered 457 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo SL Tablet is the first listed.
NCT05273749 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05273749 about?
NCT05273749 is a clinical study titled "A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia". This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.
What is the current status of trial NCT05273749?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 457 participants. The study started on 2022-04-06. Estimated completion is 2023-11-14.
What interventions are being tested in trial NCT05273749?
The interventions under investigation include: Placebo SL Tablet (DRUG), TNX-102 SL Tablet, 5.6 mg (DRUG).
Who is sponsoring clinical trial NCT05273749?
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 NCT05273749's enrollment target sits among peer trials
457 827th of 2000 higher than 1,174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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