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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: Completed Phase 2 study, sponsored by Tonix Pharmaceuticals.
NCT01903265 is a Phase 2 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 205 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Daily pain scores were assessed using a 24-hour recall response provided by each patient via an interactive voice response system (IVRS) daily telephone diary. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Jump to control was used to replace missing data in each treatment arm.
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 |
What the finished NCT01903265 record still lists
NCT01903265 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01903265 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01903265's enrollment target sits among peer trials
205 298th of 2000 higher than 1,702 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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