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NCT02829814 · ClinicalTrials.gov registry record · Phase 3
Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia
A Phase 3 study, sponsored by Tonix Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
NCT02829814 is a Phase 3 study that was terminated before completion, run by Tonix Pharmaceuticals. The registered enrollment target is 51 participants.
The verdict
NCT02829814, a Phase 3 study, was terminated before completion, sponsored by Tonix Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
Study Summary
The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia. The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.
Interventions
- DRUG Placebo SL Tablet
- DRUG TNX-102 SL Tablet, 2.8 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2016-07-22 |
| Est. Completion | 2016-09-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02829814
The ClinicalTrials.gov registry entry for NCT02829814 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 51 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 2 interventions - of which Placebo SL Tablet is the first listed.
NCT02829814 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02829814 about?
NCT02829814 is a clinical study titled "Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia". The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia. The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by t...
What is the current status of trial NCT02829814?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2016-07-22. Estimated completion is 2016-09-13.
What interventions are being tested in trial NCT02829814?
The interventions under investigation include: Placebo SL Tablet (DRUG), TNX-102 SL Tablet, 2.8 mg (DRUG).
Who is sponsoring clinical trial NCT02829814?
This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
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