CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 205 enrolled
Drug / intervention
TNX-102 SL 2.8mg +1 moredrug
Likely dose
TNX-102 SL 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/NCT01903265
NCT01903265Phase 3Completed
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A Phase 2b, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken at Bedtime in Patients With Fibromyalgia

Tonix Pharmaceuticals, Inc.·interventional·Posted Jul 19, 2013·Updated Dec 23, 2016

In Brief

A Phase 3 clinical trial evaluating TNX-102 SL 2.8mg and Placebo for Primary Fibromyalgia. Completed, enrolled 205 participants across 17 sites.

Detailed Summary

TNX-102 capsules \[formerly known as very low dose (VLD) cyclobenzaprine\] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was 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--
ConditionsPrimary Fibromyalgia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 19, 2013
Enrollment StartSep 1, 2013
Primary CompletionJul 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.0 years ago

Interventions

TNX-102 SL 2.8mgdrug

Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

Placebodrug

Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.