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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 is a Phase 3 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 375 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02589275
The ClinicalTrials.gov registry entry for NCT02589275 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 375 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tonix Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TNX-102 SL Tablet 2.8 mg is the first listed.
NCT02589275 reports 0 study locations.
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.
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