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NCT02436096 · ClinicalTrials.gov registry record · Phase 3
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.
- Completed
- Registry status
- Phase 3
- Development phase
- 519
- Enrollment target
NCT02436096: Completed Phase 3 study, sponsored by Tonix Pharmaceuticals.
NCT02436096 is a Phase 3 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 519 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02436096, a Phase 3 study, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 519 participants
- Enrollment target
Study Summary
The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology. The present trial is 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
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement (responder criteria) from baseline to Week 12 in the weekly mean of the daily self-reported 24-hour recall average pain intensity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Interventions
- DRUG Placebo SL Tablet
- DRUG TNX-102 SL Tablet, 2.8mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 519 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-09 |
| Phase | Phase 3 |
What the finished NCT02436096 record still lists
NCT02436096 is an interventional study that assigns participants to a tested intervention. The registered 519 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 (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo SL Tablet is the first listed.
NCT02436096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02436096 about?
NCT02436096 is a clinical study titled "A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia". The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM ...
What is the current status of trial NCT02436096?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 519 participants. The study started on 2015-04. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02436096?
The interventions under investigation include: Placebo SL Tablet (DRUG), TNX-102 SL Tablet, 2.8mg (DRUG).
Who is sponsoring clinical trial NCT02436096?
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 NCT02436096's enrollment target sits among peer trials
519 723rd of 2000 higher than 1,278 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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