NCT02277704 (AtEase) is a Phase 2 clinical trial of TNX-102 SL in PTSD, sponsored by Tonix Pharmaceuticals, Inc..

Who is sponsoring NCT02277704?

NCT02277704 is sponsored by Tonix Pharmaceuticals, Inc..

What drugs are being tested in NCT02277704?

Interventions in NCT02277704: TNX-102 SL, Placebo.

Is NCT02277704 still recruiting?

NCT02277704 is currently completed. Last updated 24 May 2024.

Are results published for NCT02277704?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-05-24 · How we verify

NCT02277704: AtEase

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken at Bedtime in Subjects With Military-Related PTSD and Related Conditions (Protocol No. TNX-CY-P201) -"AtEase STUDY"

Completed Phase 2 Results posted Last updated 24 May 2024

What this trial tests

Phase 2 trial testing TNX-102 SL in PTSD in 245 participants. Completed in 1 May 2016.

Timeline

1 October 2014

Primary endpoint
1 May 2016

1 May 2016

Quick facts

Lead sponsor	Tonix Pharmaceuticals, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	245
Start date	1 October 2014
Primary completion	1 May 2016
Estimated completion	1 May 2016
Sites	23 locations across United States

Drugs / interventions tested

TNX-102 SL — full drug profile →
Placebo

Conditions studied

PTSD — all drugs for PTSD →

Sponsor

Tonix Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with PTSD. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).
Time frame: Day 1, Week 12
The mean change from baseline (Visit 2) in the Total CAPS-5 score after 12 weeks of treatment evaluated at Visit 9 (Week 12). The primary efficacy comparison will be the change from baseline in total CAPS-5 score for the 2.8 mg treatment arm compared to placebo. CAPS-5 score ranges from 0-80 with lower scores indicating less severe PTSD symptoms.

Sponsor's own description

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL -a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly visits for assessments of efficacy and safety.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response.
Sullivan GM, Gendreau RM, Gendreau J, Peters P, et al · · 2021 · cited 10× · PMID 33979763 · DOI 10.1016/j.psychres.2021.113974
Anxiety disorders, PTSD and OCD: systematic review of approved psychiatric medications (2008-2024) and pipeline phase III medications.
Tadros E, Keerthana S, Padder S, Totlani J, et al · · 2025 · cited 3× · PMID 40225810 · DOI 10.7573/dic.2024-11-2

Verify or expand the search:

Other trials of TNX-102 SL

Trials testing the same drug.

NCT05372887 — Safety and Efficacy Study of TNX-102 SL in Participants With PTSD · Phase 2 · withdrawn
NCT05472090 — A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post- · Phase 2 · completed
NCT07464535 — A Single-Dose, Randomized, Open-Label, 2-Way Crossover Study to Evaluate the Dose-Proportionality, Safety, and Tolerabil · Phase 1 · completed
NCT04508621 — A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia · Phase 3 · completed
NCT04172831 — A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia · Phase 3 · completed

Other recruiting trials for PTSD

Currently open trials in the same condition.

NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting
NCT07010757 — Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial · NA · recruiting
NCT07372586 — Behavioral Health Collaborative Care Model in an ICU Recovery Clinic · NA · recruiting
NCT07390786 — Behavioral Health Collaborative Care Model in Post-ICU Clinic Family Pilot · NA · recruiting
NCT07469098 — Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events · Phase 2 · recruiting

Other Tonix Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT07413367 — A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine · Phase 1 · active not recruiting
NCT06045793 — Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (C · Phase 2 · terminated
NCT07473752 — A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Escalation Study to Evaluate the Safety, · Phase 1 · completed
NCT05686408 — Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) · Phase 2 · completed
NCT05679908 — A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02277704 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tonix Pharmaceuticals, Inc.
Last refreshed: 24 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02277704.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing