CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 519 enrolled
Drug / intervention
TNX-102 SL Tablet, 2.8mg +1 moredrug
Likely dose
TNX-102 SL Tablet, 2.8mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02436096
NCT02436096Phase 3Completed
CompareCT.gov

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

Tonix Pharmaceuticals, Inc.·interventional·Posted May 6, 2015·Updated Feb 7, 2025

In Brief

A Phase 3 clinical trial evaluating TNX-102 SL Tablet, 2.8mg and Placebo SL Tablet for Fibromyalgia and 6 related conditions. Completed, enrolled 519 participants across 35 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Musculoskeletal Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 6, 2015
Enrollment StartApr 1, 2015
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.2 years ago

Interventions

TNX-102 SL Tablet, 2.8mgdrug

Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.

Placebo SL Tabletdrug

Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.