NCT02829814

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, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The EFFIcacy and Safety of TNX-102 SL Tablets Taken Daily At Bedtime In Patients With FibRoMyalgia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia
• Myofascial Pain Syndromes
• Muscular Diseases
• Nervous System Diseases
• Neuromuscular Diseases
• Rheumatic Diseases
• Musculoskeletal Diseases

Interventions

Type	Name	Description
DRUG	TNX-102 SL Tablet, 2.8 mg	Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
DRUG	Placebo SL Tablet	Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

Timeline

• Start date: 2016-07-22
• Primary completion: 2016-09-13
• Completion: 2016-09-13
• First posted: 2016-07-12
• Last updated: 2025-02-25
• Results posted: 2025-02-25

Locations

32 sites across 1 country: United States