AzTrials
AzTrials

PTSDPhase 3HONORNCT03062540

Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

A Phase 3 study testing TNX-102 SL in people with PTSD, run by Tonix Pharmaceuticals, Inc. at 44 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
PTSD
What is being tested?
TNX-102 SL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
358 participants
Where
44 sitesUnited States
Study dates
27 Mar 2017to 27 Jul 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female between 18 and 75 years of age, who have served in any branch of the military.
  • Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5.
  • Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related.
  • Willing to refrain from use of all other formulations of cyclobenzaprine.
  • Willing and able to refrain from antidepressants and other excluded medications.
  • Capable of reading and understanding English and able to provide written informed consent.
  • If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
  • Willing and able to comply with all protocol-specified requirements.

Who cannot join

  • Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol.
  • Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history.
  • Severe depressive symptoms at screening or baseline.
  • Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion.
  • Use of antidepressant medication within 2 months of baseline.
  • Female patients who are pregnant or lactating.
Show all 12Show fewer
  • History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients.
  • Seizure disorder.
  • Patients with a body mass index (BMI) > 45.
  • Has received any other investigational drug within 30 days before Screening.
  • Previous participation in any other study with TNX-102 SL.
  • Family member of investigative staff.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Atlanta

    Atlanta, Georgia, 30341

  • Austin

    Austin, Texas, 78754

  • Berlin

    Berlin, New Jersey, 08009

  • Beverly hills

    Beverly Hills, California, 90210

  • Canton

    Canton, Ohio, 44718

  • Cedarhurst

    Cedarhurst, New York, 11516

  • Charleston

    Charleston, South Carolina, 29407

  • Chicago

    Chicago, Illinois, 60640

  • Cincinnati

    Cincinnati, Ohio, 45219

  • Colorado Springs

    Colorado Springs, Colorado, 80910

  • Cromwell

    Cromwell, Connecticut, 06416

  • Dallas

    Dallas, Texas, 75231

  • Dayton

    Dayton, Ohio, 45417

  • Downingtown

    Downingtown, Pennsylvania, 19335

  • Everett

    Everett, Washington, 98201

  • Flowood

    Flowood, Mississippi, 39232

  • Glendale

    Glendale, California, 91206

  • Houston

    Houston, Texas, 77098

  • Jacksonville

    Jacksonville, Florida, 32256

  • Lake City

    Lake City, Florida, 32607

  • Las Vegas

    Las Vegas, Nevada, 89102

  • Lauderhill

    Lauderhill, Florida, 33319

  • Little Rock

    Little Rock, Arkansas, 72211

  • Maitland

    Maitland, Florida, 32751

  • Media

    Media, Pennsylvania, 19063

  • Missoula

    Missoula, Montana, 59812

  • New Bedford

    New Bedford, Massachusetts, 02740

  • New York

    New York, New York, 10128

  • Norwich

    Norwich, Connecticut, 06360

  • Oakland

    Oakland, California, 94607

  • Oceanside

    Oceanside, California, 92056

  • Oklahoma City

    Oklahoma City, Oklahoma, 73103

  • Orange

    Orange, California, 92868

  • Phoenix

    Phoenix, Arizona, 85032

  • Riverside

    Riverside, California, 92506

  • Rogers

    Rogers, Arkansas, 72758

  • Salem

    Salem, Virginia, 24153

  • San Antonio

    San Antonio, Texas, 78229

  • San Diego

    San Diego, California, 92123

  • San Diego

    San Diego, California, 92161

  • St. Louis

    St Louis, Missouri, 63141

  • Tampa

    Tampa, Florida, 33609

  • Temecula

    Temecula, California, 92591

  • Washington, D.C.

    Washington D.C., District of Columbia, 20018

Other trials in United States

About this study

Official title: A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily at Bedtime in Patients With Military-Related PTSD

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

Conditions
PTSD
Being tested
TNX-102 SL, Placebo SL Tablet
Keywords
PTSD, Military-related PTSD
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TNX-102 SLDrug

    Also called Low dose cyclobenzaprine sublingual tablets

    Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks

  • Placebo SL TabletDrug

    Also called Placebo sublingual tablets

    Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks

Study groups in NCT03062540
Study groupRoleWhat they receive
TNX-102 SL Tablet, 5.6 mgExperimental2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
Receives: Drug: TNX-102 SL
Placebo SL TabletPlacebo comparator2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Receives: Drug: Placebo SL Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.

    To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) total symptom severity score in a 12-week study. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms.

    Measured: Day 0 and Week 12

Secondary outcomes (4)

  1. Clinical Global Impression - Improvement From Initiation of Treatment (CGI-I) Score After 12 Weeks of Treatment.

    To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the CGI-I score after 12 weeks of treatment. Score ranges from 1 to 7. 1 = Very much improved. 2 = Much improved. 3 = Minimally improved. 4 = No change. 5 = Minimally worse. 6 = Much worse. 7 = Very much worse.

    Measured: Week 12

  2. Change From Baseline in the Disruption of Social Life/Leisure Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment.

    To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of social life/leisure activities assessed with the SDS after 12 weeks of treatment. Score ranges from 0 to 10. Lower scores indicate less disruption to social life/leisure activities.

    Measured: Day 0, Week 12.

  3. Change From Baseline in the Disruption of Work/School Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment.

    To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of work/school activities assessed with the SDS after 12 weeks of treatment. Score ranges from 0 to 10. Lowers scores indicate less disruption to work/school activities.

    Measured: Day 0, Week 12.

  4. Change From Baseline in Patients' Quality of Sleep Using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance Scale After 12 Weeks of Treatment.

    To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in quality of sleep using the PROMIS Sleep Disturbance scale after 12 weeks of treatment. Raw score is transformed to T-scores using published conversions. T-score ranges from 30 to 80 with lower scores indicating better sleep quality.

    Measured: Day 0, Week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study start27 Mar 2017
  3. Primary completion27 Jul 2018
  4. Study completion27 Jul 2018

Why it stopped: Stopped early due to inadequate separation on primary efficacy endpoint at Week 12 according to Interim Analysis conducted on the first 274 (50%) patients.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03062540
Sponsor's protocol ID
TNX-CY-P301
Acronym
HONOR
Status last verified
Apr 2024
First submitted
20 Feb 2017
Last updated
22 May 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Parmenter ME, Lederman S, Weathers FW, Davis LL, Vaughn B, Engels J, Sullivan GM. A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder. Psychiatry Res. 2024 Apr;334:115764. doi: 10.1016/j.psychres.2024.115764. Epub 2024 Feb 1.

    PubMed 38350291

  • Dunlop BW, Rakofsky JJ, Newport DJ, Mletzko-Crowe T, Barone K, Nemeroff CB, Harvey PD. Efficacy of Vortioxetine Monotherapy for Posttraumatic Stress Disorder: A Randomized, Placebo-Controlled Trial. J Clin Psychopharmacol. 2021 Mar-Apr 01;41(2):172-179. doi: 10.1097/JCP.0000000000001363.

    PubMed 33587394

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TNX-102 SL in people with PTSD, run by Tonix Pharmaceuticals, Inc. at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12. (time frame: Day 0 and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03062540, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in