CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 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/NCT05472090
NCT05472090Phase 2Completed
CompareCT.gov

A Phase 2, 14-week Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily at Bedtime in Patients With Multisite Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Tonix Pharmaceuticals, Inc.·interventional·Posted Jul 25, 2022·Updated Nov 26, 2024

In Brief

A Phase 2 clinical trial evaluating TNX-102 SL and Placebo SL Tablet for Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection and 3 related conditions. Completed, enrolled 63 participants across 29 sites.

Detailed Summary

This is a Phase 2, 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 once daily at bedtime for the management of multi-site pain associated with Long COVID.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Acute Sequelae of SARS-CoV-2 (PASC) Infection, COVID-19, Long COVID, Long Haul COVID
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedJul 25, 2022
Enrollment StartAug 18, 2022
Primary CompletionJul 12, 2023
Study CompletionJul 27, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 3.9 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.