PTSDPhase 3RECOVERYNCT03841773
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
A Phase 3 study testing TNX-102 SL in people with PTSD, run by Tonix Pharmaceuticals, Inc. at 30 sites in United States.
Trial summary
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (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
- 192 participants
- Where
- 30 sitesUnited States
- Study dates
- 7 Mar 2019to 24 Apr 2020
- 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 and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening)
- Index trauma must have occurred within 9 years of Screening Visit
- Must have occurred when the patient was ≥18 years of age
Who cannot join
- Use of antidepressant medication within 2 months of Baseline
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Ashild Peters
Alpharetta, Georgia, 30341
Ashild Peters
Austin, Texas, 78737
Ashild Peters
Beverly Hills, California, 90210
Ashild Peters
Boston, Massachusetts, 02131
Ashild Peters
Colorado Springs, Colorado, 80910
Ashild Peters
Dallas, Texas, 75231
Ashild Peters
Flowood, Mississippi, 39232
Ashild Peters
Jacksonville, Florida, 32256
Ashild Peters
Las Vegas, Nevada, 89102
Ashild Peters
Lincolnwood, Illinois, 60712
Ashild Peters
Little Rock, Arkansas, 72211
Ashild Peters
Memphis, Tennessee, 38119
Ashild Peters
New Bedford, Massachusetts, 02740
Ashild Peters
North Miami, Florida, 33161
Ashild Peters
Norwich, Connecticut, 06360
Ashild Peters
Oceanside, California, 92056
Ashild Peters
Oklahoma City, Oklahoma, 73106
Ashild Peters
Orange, California, 92868
Ashild Peters
Orlando, Florida, 32801
Ashild Peters
Panorama City, California, 91402
Ashild Peters
Phoenix, Arizona, 85012
Ashild Peters
Portland, Oregon, 97214
Ashild Peters
Riverside, California, 92506
Ashild Peters
Rogers, Arkansas, 72758
Ashild Peters
Salem, Oregon, 97301
Ashild Peters
San Diego, California, 92123
Ashild Peters
St Louis, Missouri, 63141
Ashild Peters
Tampa, Florida, 33614
Ashild Peters
Temecula, California, 92591
Ashild Peters
Washington D.C., District of Columbia, 20011
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 in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (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 Tablets
- Keywords
- 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, Tonmya(R)
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
Placebo SL TabletsDrug
Also called Placebo sublingual tablets, TNX-102 SL Placebo Tablets
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| TNX-102 SL Tablet 2.8 mg | Experimental | 2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks. Receives: Drug: TNX-102 SL |
| Placebo SL Tablet | Placebo comparator | 2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks. Receives: Drug: Placebo SL Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in the Total CAPS-5 Score
The primary efficacy endpoint is the mean change from baseline (Day 1) in the total CAPS-5 score after 12 weeks of treatment. The CAPS-5 is an updated and validated version of a semi-structured interview that has been designed to assess the essential features of PTSD as defined by the DSM-5. The total score ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms.
Measured: Day 1, Week 12
Secondary outcomes (3)
Clinical Global Impression of Severity (CGI-S)
Change from baseline (Day 1) in CGI-S score at Week 12. CGI-S range from 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients).
Measured: Day 1, Week 12
Sheehan Disability Scale (SDS)
Change from baseline in Sheehan Disability Scale (SDS) total score after 12 weeks of treatment comparing the 5.6 mg treatment arm to placebo. The SDS is a self-report questionnaire that was designed to assess the participant's view of the degree to which symptoms have disrupted work/school, social life/leisure activities, and family life/home responsibilities during the previous two weeks. Score ranges from 0 to 30. A score of 0 means the patient is unimpaired, and a score of 30 means the patient is highly impaired.
Measured: Day 1, Week 12
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance
Change from baseline (Day 1) to Week 12 in the PROMIS Sleep Disturbance scale. The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.
Measured: Day 1, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start7 Mar 2019
- Primary completion24 Apr 2020
- Study completion24 Apr 2020
Why it stopped: Interim Analysis results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory M Sullivan, MD, Study director, Tonix Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841773
- Sponsor's protocol ID
- TNX-CY-P302
- Acronym
- RECOVERY
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2019
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)
- ClinicalTrials.gov ID
- NCT03841773
- Acronym / sponsor ID
- RECOVERY / TNX-CY-P302
- Conditions
- PTSD
- Keywords
- PTSD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim Analysis results
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNX-102 SL Tablet 2.8 mg | Experimental | Drug: TNX-102 SL2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks. |
| Placebo SL Tablet | Placebo comparator | Drug: Placebo SL Tablets2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening)
- Index trauma must have occurred within 9 years of Screening Visit
- Must have occurred when the patient was ≥18 years of age
Key exclusion criteria (1 listed)
- Use of antidepressant medication within 2 months of Baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNX-102 SLAlso: Low dose cyclobenzaprine sublingual tablets, Tonmya(R)Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks | Drug | TNX-102 SL Tablet 2.8 mg |
| Placebo SL TabletsAlso: Placebo sublingual tablets, TNX-102 SL Placebo TabletsPatients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks | Drug | Placebo SL Tablet |
Primary outcome
Mean Change From Baseline in the Total CAPS-5 Score
Time frame: Day 1, Week 12
The primary efficacy endpoint is the mean change from baseline (Day 1) in the total CAPS-5 score after 12 weeks of treatment. The CAPS-5 is an updated and validated version of a semi-structured interview that has been designed to assess the essential features of PTSD as defined by the DSM-5. The total score ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms.
3 secondary outcomes
Clinical Global Impression of Severity (CGI-S)
Time frame: Day 1, Week 12
Sheehan Disability Scale (SDS)
Time frame: Day 1, Week 12
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance
Time frame: Day 1, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory M Sullivan, MD study director
Tonix Pharmaceuticals
30 sites in 1 country: see every site and its status.
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 30 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 3 inclusion and 1 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 6 Feb 2025). 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 CAPS-5 Score (time frame: Day 1, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2025.