Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04172831 · ClinicalTrials.gov registry record · Phase 3
A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
A Phase 3 study, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 503
- Enrollment target
NCT04172831: Completed Phase 3 study, sponsored by Tonix Pharmaceuticals.
NCT04172831 is a Phase 3 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 503 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04172831, a Phase 3 study, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 503 participants
- Enrollment target
Study Summary
This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.
Primary Outcome
Patients provide a daily numeric assessment of their average pain (24-hour recall), via an electronic diary, using an 11-point NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Interventions
- DRUG TNX-102 SL
- DRUG Placebo SL Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 503 participants |
| Start Date | 2019-12-09 |
| Est. Completion | 2020-10-29 |
| Phase | Phase 3 |
What the finished NCT04172831 record still lists
NCT04172831 is an interventional study that assigns participants to a tested intervention. The registered 503 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 (35% lower).
The record links to 0 conditions, and to 2 interventions - of which TNX-102 SL is the first listed.
NCT04172831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04172831 about?
NCT04172831 is a clinical study titled "A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia". This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.
What is the current status of trial NCT04172831?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 503 participants. The study started on 2019-12-09. Estimated completion is 2020-10-29.
What interventions are being tested in trial NCT04172831?
The interventions under investigation include: TNX-102 SL (DRUG), Placebo SL Tablet (DRUG).
Who is sponsoring clinical trial NCT04172831?
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 NCT04172831's enrollment target sits among peer trials
503 743rd of 2000 higher than 1,258 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
- NCT05143931 · 503 participants · NA
Avoid and Resist Strategies for Weight Management
- NCT05846282 · 504 participants · NA
Students Rising Above: Offsetting the Health and Mental Health Costs of Resilience
- NCT06072131 · 504 participants · Phase 3
To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
- NCT06736522 · 504 participants · NA
Future Leaders Program: Testing a Youth Leadership, Engagement, and Mindfulness Program
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