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NCT01903265 · ClinicalTrials.gov registry record · Phase 2
BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
A Phase 2 study, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 205
- Enrollment target
NCT01903265 is a Phase 2 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 205 participants.
The verdict
NCT01903265, a Phase 2 study, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 205 participants
- Enrollment target
Study Summary
TNX-102 capsules \[formerly known as very low dose (VLD) cyclobenzaprine\] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.
Interventions
- DRUG Placebo
- DRUG TNX-102 SL 2.8mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01903265
The ClinicalTrials.gov registry entry for NCT01903265 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 205 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 is the first listed.
NCT01903265 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01903265 about?
NCT01903265 is a clinical study titled "BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)". TNX-102 capsules \[formerly known as very low dose (VLD) cyclobenzaprine\] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, ta...
What is the current status of trial NCT01903265?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 205 participants. The study started on 2013-09. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01903265?
The interventions under investigation include: Placebo (DRUG), TNX-102 SL 2.8mg (DRUG).
Who is sponsoring clinical trial NCT01903265?
This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
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