PTSDPhase 2P202NCT02421679
Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
A Phase 2 study testing TNX-102 SL in people with PTSD, run by Tonix Pharmaceuticals, Inc. at 22 sites in United States.
Trial summary
This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Read more about this study
- Who is it for?
- Ages 18 to 65 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?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 22 sitesUnited States
- Study dates
- 14 Apr 2015to 26 May 2016
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed the lead-in study and is judged as reasonably compliant, with at least 60% compliance
- Signed informed consent
- Met all prior inclusion and exclusion requirements for lead-in study
- No new or worsening medical conditions since starting the lead-in study that could pose a safety risk or interfere with participation in the study
- Willing to refrain from use of specific medication (ask PI)
- Female patients of childbearing potential continue to practice medically acceptable methods of birth control
Who cannot join
- None
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Atlanta Center For Medical Research
Atlanta, Georgia, 30308
Northwest Clinical Research Center
Bellevue, Washington, 98007
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Great Lakes Clinical Trials
Chicago, Illinois, 60640
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Sun Valley Research Center
Imperial, California, 92251
Sarkis Clinical Trials
Lake City, Florida, 32025
Altea Research
Las Vegas, Nevada, 89102
Compass Research North, LLC
Leesburg, Florida, 34748
Premier Psychiatric Research Institute, Inc.
Lincoln, Nebraska, 68526
Synergy Clinical Research
National City, California, 91950
Novex Clinical Research
New Bedford, Massachusetts, 02740
Excell Research, Inc
Oceanside, California, 92506
Neuropsychiatric Research Center of Orange County
Orange, California, 92868
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Noesis Pharma
Phoenix, Arizona, 85032
CITRIALS
Riverside, California, 92506
Clinical Trials of Texas
San Antonio, Texas, 78229
CESAMH
San Diego, California, 92103
Cns, Inc.
Torrance, California, 90502
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, 35404
About this study
Official title: A 12-Week, Open-Label, Multicenter, Extension Study To TNX-CY-P201 To Evaluate The Safety And Efficacy Of TNX-102 SL Taken Daily At Bedtime In Patients With Military-Related PTSD And Related Conditions
This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-P201 (AtEase Study) [NCT02277704]. Patients will not be made aware of the therapy they received during the double-blind study.
Read the detailed description
The study will consist of 4 clinic visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as the final visit in the lead-in P201 study) and visits after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for refraining from the use of certain concomitant medications and trauma-focused psychotherapies will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or they may utilize other medications as needed to help them sleep, per the judgment of the investigator.
Eligible patients who provide written informed consent will take one TNX-102 SL tablet daily at bedtime sublingually (under the tongue) for 12 weeks. All patients will be assigned to receive tthe same dosage of TNX-102 SL, regardless of their treatment assignment in the lead-in study. No patients, investigators, or study staff will know the assigned study treatment from the lead-in study, P201, at the time of entry into the extension study. Patient data collected at the Week 12 visit (Visit 9) in the lead-in P201 study will be used as one of the baseline values for this study.
- Conditions
- PTSD
- Being tested
- TNX-102 SL
- Keywords
- PTSD, Military-related PTSD and other related conditions, open-label extension
- 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 cyclobenzaprine HCI
1x 2.8mg TNX-102 SL Sublingual tablet
| Study group | Role | What they receive |
|---|---|---|
| TNX-102 SL | Experimental | TNX-102 SL taken daily at bedtime for 12 weeks Receives: Drug: TNX-102 SL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newly Treatment Emergent Adverse Events
Number of patients with new treatment emergent AEs since completing lead-in study
Measured: Week 12
Secondary outcomes (5)
Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5)
Changes in total CAPS-5 score from baseline in lead-in study and since baseline in this study. CAPS-5 score ranges from 0-80 with lower scores indicating less sever PTSD symptoms.
Measured: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Response Rates a in Total CAPS-5 Score
≥30% decrease in Total CAPS-5 score from baseline in lead-in study and since baseline in this study. Lower scores on CAPS-5 indicate less severe PTSD symptoms.
Measured: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P201 Week 12
CAPS-5 Cluster Score Items
Changes from baseline in lead-in study and since baseline in this study in item scores, including
- intrusion symptoms (Criterion B) - Score ranges from 0 to 20.
- CAPS-5 item 2. (B-2) (unpleasant dreams related to the trauma) - Score ranges from 0 to 4
- persistent avoidance (Criterion C) - Score ranges from 0 to 8
- negative cognitions and mood (Criterion D) - Score ranges from 0 to 28
- arousal and reactivity (Criterion E) - Score ranges from 0 to 24 Lower scores indicate less severe symptoms on all items
Measured: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Montgomery-Asberg Depression Rating Scale
Changes from baseline in lead-in study and since baseline in this study in MADRS. Score ranges from 0 to 60. Lower scores indicate less severe depression symptoms.
Measured: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
PROMIS (Patient -Reported Outcome Measurement Information System)
Changes from baseline in lead-in study and since baseline in this study in PROMIS scores. Raw scores are converted to T-scores with mean of 50 and standard deviation of 10 using published conversion tables based on the US population.
- Fatigue T-score ranges from 33.1 to 77.8. Lower scores indicate less fatigue
- Sleep Disturbance T-score ranges from 28.9 to 76.5. Lower scores indicate less sleep disturbance
- Global Physical Health T-score ranges from 16.2 to 67.7. Lower scores indicate better physical health
- Global Mental Health T-score ranges from 21.2 to 67.6. Lower scores indicate better mental health
Measured: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start14 Apr 2015
- Primary completion26 May 2016
- Study completion26 May 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denise Bedoya, Study director, Premier Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421679
- Sponsor's protocol ID
- TNX-CY-P202
- Acronym
- P202
- Status last verified
- Feb 2025
- First submitted
- 9 Apr 2015
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 12-Week, Open-Label, Multicenter, Extension Study To TNX-CY-P201 To Evaluate The Safety And Efficacy Of TNX-102 SL Taken Daily At Bedtime In Patients With Military-Related PTSD And Related Conditions
- ClinicalTrials.gov ID
- NCT02421679
- Acronym / sponsor ID
- P202 / TNX-CY-P202
- Conditions
- PTSD
- Keywords
- PTSD, Military-related PTSD and other related conditions, open-label extension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2015 (actual)
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 26 May 2016 (actual)
- First posted
- 21 Apr 2015 (estimated)
- 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, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-P201 (AtEase Study) [NCT02277704]. Patients will not be made aware of the therapy they received during the double-blind study.
Detailed description
The study will consist of 4 clinic visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as the final visit in the lead-in P201 study) and visits after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for refraining from the use of certain concomitant medications and trauma-focused psychotherapies will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or they may utilize other medications as needed to help them sleep, per the judgment of the investigator.
Eligible patients who provide written informed consent will take one TNX-102 SL tablet daily at bedtime sublingually (under the tongue) for 12 weeks. All patients will be assigned to receive tthe same dosage of TNX-102 SL, regardless of their treatment assignment in the lead-in study. No patients, investigators, or study staff will know the assigned study treatment from the lead-in study, P201, at the time of entry into the extension study. Patient data collected at the Week 12 visit (Visit 9) in the lead-in P201 study will be used as one of the baseline values for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNX-102 SL | Experimental | Drug: TNX-102 SLTNX-102 SL taken daily at bedtime for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Completed the lead-in study and is judged as reasonably compliant, with at least 60% compliance
- Signed informed consent
- Met all prior inclusion and exclusion requirements for lead-in study
- No new or worsening medical conditions since starting the lead-in study that could pose a safety risk or interfere with participation in the study
- Willing to refrain from use of specific medication (ask PI)
Key exclusion criteria (1 listed)
- None
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: cyclobenzaprine HCI1x 2.8mg TNX-102 SL Sublingual tablet | Drug | TNX-102 SL |
Primary outcome
Newly Treatment Emergent Adverse Events
Time frame: Week 12
Number of patients with new treatment emergent AEs since completing lead-in study
5 secondary outcomes
Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5)
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Response Rates a in Total CAPS-5 Score
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P201 Week 12
CAPS-5 Cluster Score Items
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Montgomery-Asberg Depression Rating Scale
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
PROMIS (Patient -Reported Outcome Measurement Information System)
Time frame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 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.
Denise Bedoya study director
Premier Research
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNX-102 SL in people with PTSD, run by Tonix Pharmaceuticals, Inc. at 22 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 6 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: finished, 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 22 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Newly Treatment Emergent Adverse Events (time frame: 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.