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NCT02589275 · ClinicalTrials.gov registry record · Phase 3
A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients
A Phase 3 study, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 375
- Enrollment target
NCT02589275: Completed Phase 3 study, sponsored by Tonix Pharmaceuticals.
NCT02589275 is a Phase 3 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 375 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02589275, a Phase 3 study, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 375 participants
- Enrollment target
Study Summary
This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302. Patients will not be made aware of the therapy they received during the double-blind study.
Primary Outcome
The number of patients with at least one adverse event which began after the first dose of TNX-102 SL in this open-label extension study.
Interventions
- DRUG TNX-102 SL Tablet 2.8 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2015-08-04 |
| Est. Completion | 2016-09-28 |
| Phase | Phase 3 |
What the finished NCT02589275 record still lists
NCT02589275 is an interventional study that assigns participants to a tested intervention. The registered 375 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 (51% lower).
The record links to 0 conditions, and to 1 intervention - of which TNX-102 SL Tablet 2.8 mg is the first listed.
NCT02589275 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02589275 about?
NCT02589275 is a clinical study titled "A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients". This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studie...
What is the current status of trial NCT02589275?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 375 participants. The study started on 2015-08-04. Estimated completion is 2016-09-28.
What interventions are being tested in trial NCT02589275?
The interventions under investigation include: TNX-102 SL Tablet 2.8 mg (DRUG).
Who is sponsoring clinical trial NCT02589275?
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 NCT02589275's enrollment target sits among peer trials
375 988th of 2000 higher than 1,010 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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