CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 158 enrolled
Drug / intervention
TNX-102 SLdrug
Likely dose
TNX-102 SL 2.8 mgfrom 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/NCT02015234
NCT02015234Phase 3Completed
CompareCT.gov

A 12-Month, Multicenter, Open-Label Extension Study (F202) to Evaluate the Long-term Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia

Tonix Pharmaceuticals, Inc.·interventional·Posted Dec 19, 2013·Updated Jul 7, 2017

In Brief

A Phase 3 clinical trial evaluating TNX-102 SL for Primary Fibromyalgia. Completed, enrolled 158 participants across 13 sites.

Detailed Summary

This was an open-label, extension trial designed to evaluate the long-term safety over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia. Patients recruited into this trial were those who had successfully completed the double-blind study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they received during the double-blind study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Fibromyalgia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 19, 2013
Enrollment StartDec 1, 2013
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.5 years ago

Interventions

TNX-102 SLdrug

TNX-102 SL 2.8 mg taken daily at bedtime.