NCT05273749

A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia

A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	TNX-102 SL Tablet, 5.6 mg	Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
DRUG	Placebo SL Tablet	Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.

Timeline

• Start date: 2022-04-06
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2022-03-10
• Last updated: 2025-01-22
• Results posted: 2024-12-20

Locations

33 sites across 1 country: United States

Regulatory

• FDA-regulated drug study