Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 3 study, sponsored by Tonix Pharmaceuticals.
NCT02829814 is a Phase 3 study that was terminated before completion, run by Tonix Pharmaceuticals. The registered enrollment target is 51 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) numeric response scale (NRS). A score of 0 indicates "no pain at all", and a score of 10 indicates "worst possible pain".
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 |
Why NCT02829814 stopped before completion
NCT02829814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo SL Tablet is the first listed.
NCT02829814 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02829814's enrollment target sits among peer trials
51 1842nd of 2000 higher than 157 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02701153 · 51 participants · NA
Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
- NCT03663790 · 51 participants · NA
Effects of Gait Retraining on Lower Extremity Biomechanics
- NCT03874052 · 51 participants · Phase 1
Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
- NCT04704661 · 51 participants · Phase 1
Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI