CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 503 enrolled
Drug / intervention
TNX-102 SL +1 moredrug
Likely dose
Not stated in 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/NCT04172831
NCT04172831Phase 3Completed
CompareCT.gov

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

Tonix Pharmaceuticals, Inc.·interventional·Posted Nov 21, 2019·Updated Aug 8, 2022

In Brief

A Phase 3 clinical trial evaluating TNX-102 SL and Placebo SL Tablet for Fibromyalgia. Completed, enrolled 503 participants across 39 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 21, 2019
Enrollment StartDec 9, 2019
Primary CompletionOct 29, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.6 years ago

Interventions

TNX-102 SLdrug

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.

Placebo SL Tabletdrug

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.