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NCT04508621 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
A Phase 3 study, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 514
- Enrollment target
NCT04508621: Completed Phase 3 study, sponsored by Tonix Pharmaceuticals.
NCT04508621 is a Phase 3 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 514 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04508621, a Phase 3 study, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 514 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
Patients provide a daily numeric assessment of their average pain (24-hour recall), via an electronic diary, using an 11-point NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Interventions
- DRUG TNX-102 SL
- DRUG Placebo SL Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2020-07-22 |
| Est. Completion | 2021-11-01 |
| Phase | Phase 3 |
What the finished NCT04508621 record still lists
NCT04508621 is an interventional study that assigns participants to a tested intervention. The registered 514 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 (33% lower).
The record links to 0 conditions, and to 2 interventions - of which TNX-102 SL is the first listed.
NCT04508621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04508621 about?
NCT04508621 is a clinical study titled "A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL 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 NCT04508621?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2020-07-22. Estimated completion is 2021-11-01.
What interventions are being tested in trial NCT04508621?
The interventions under investigation include: TNX-102 SL (DRUG), Placebo SL Tablet (DRUG).
Who is sponsoring clinical trial NCT04508621?
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 NCT04508621's enrollment target sits among peer trials
514 724th of 2000 higher than 1,274 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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