At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 375 enrolled
Drug / intervention
TNX-102 SL Tablet 2.8 mgdrug
Likely dose
TNX-102 SL Tablet 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.
A 3-Month, Multicenter, Open-Label Extension to Evaluate Safety and Efficacy of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia
In Brief
A Phase 3 clinical trial evaluating TNX-102 SL Tablet 2.8 mg for Primary Fibromyalgia. Completed, enrolled 375 participants across 33 sites.
Detailed Summary
This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302. Patients will not be 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
20162017201820192020202120222023202420252026
Enrollment StartAug 2015
First PostedOct 2015
Primary CompletionSep 2016
TodayJul 2026
First PostedOct 28, 2015
Enrollment StartAug 4, 2015
Primary CompletionSep 28, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.7 years ago
Interventions
TNX-102 SL Tablet 2.8 mgdrug
TNX-102 SL 2.8 mg tablet taken daily at bedtime