PTSDPhase 2NCT05372887
Safety and Efficacy Study of TNX-102 SL in Participants With PTSD
A Phase 2 study testing TNX-102 SL in people with PTSD, run by Tonix Pharmaceuticals, Inc. at 3 sites in Kenya.
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
- 0 participants
- Where
- 3 sitesKenya
- Study dates
- 14 Oct 2022to 8 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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, at the time of signing ICF, inclusive.
- Diagnosed with current (past month) PTSD as determined by the MINI 7.0.2 Module H (PTSD).
- Index trauma(s) resulting in PTSD must meet DSM-5 Criterion A for PTSD as described in the CAPS 5, must have occurred within 9 years of Screening Visit 1, and must have occurred when the participant was ≥18 years of age.
- Willing and able to withdraw and refrain from opioids for the course of the study.
- Willing to refrain from use of all other formulations of cyclobenzaprine for the course of the study.
- Willing and able to refrain from antidepressants and other excluded medications.
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- Capable of reading and understanding English and able to provide written informed consent to participate.
- Willing to comply with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
- Body mass index (BMI) within the range 17.5 - 35 kg/m^2 (inclusive).
Who cannot join
- Current or ongoing exposure to the trauma that resulted in the PTSD (ie, non-work-related trauma such as ongoing domestic abuse).
- 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 (eg, 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.
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- Female participants who are pregnant or lactating.
- History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients in TNX-102 SL or placebo formulations.
- Seizure disorder.
- Current moderate or severe sleep apnea not well controlled by positive airway pressure (PAP) or oral (mouthpiece) devices.
- Has received any other investigational drug within 90 days before Screening or has taken cyclobenzaprine within 21 days of the Randomization visit.
- Previous participation in any other study with TNX-102 SL.
- Family member of investigative staff.
Trial locations and contacts
3 sites in 1 country.
Kenya3 sites
Aga Khan University Clinical Research Unit
Nairobi
Centre for Clinical Research at KEMRI-Nairobi
Nairobi
Moi University Clinical Research Centre
Nairobi
About this study
Official title: A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Daily Bedtime TNX-102 SL in Participants With 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
- 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 1 for 12 weeks
PlaceboDrug
Also called Placebo sublingual tablets
Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| TNX-102 SL, 5.6 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 | Placebo comparator | 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, fifth edition (CAPS-5) total symptom severity score in a 12-week study.
Measured: Day 1, Week 4, Week 12
Secondary outcomes (2)
Clinical Global Impression - Severity change from Baseline to Week 12
CGI-S to assess global severity change from baseline to Week 12
Measured: Day 1, Week 4, Week 8, Week 12
Change from baseline in the disruption of psychosocial functioning assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment.
SDS to assess psychosocial functioning change from baseline to Week 12
Measured: Day 1, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start14 Oct 2022
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Why it stopped: The study was stopped due to business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Sullivan, MD, Study director, Tonix Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372887
- Sponsor's protocol ID
- TNX-CY-P308
- Status last verified
- Dec 2023
- First submitted
- 9 May 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Daily Bedtime TNX-102 SL in Participants With PTSD
- ClinicalTrials.gov ID
- NCT05372887
- Acronym / sponsor ID
- TNX-CY-P308
- Conditions
- PTSD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped due to business reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
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 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.
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, 5.6 mg | Experimental | Drug: TNX-102 SL2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks. |
| Placebo | Placebo comparator | Drug: Placebo2 x Placebo Tablet 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 (10 listed)
- Male or female between 18 and 75 years of age, at the time of signing ICF, inclusive.
- Diagnosed with current (past month) PTSD as determined by the MINI 7.0.2 Module H (PTSD).
- Index trauma(s) resulting in PTSD must meet DSM-5 Criterion A for PTSD as described in the CAPS 5, must have occurred within 9 years of Screening Visit 1, and must have occurred when the participant was ≥18 years of age.
- Willing and able to withdraw and refrain from opioids for the course of the study.
- Willing to refrain from use of all other formulations of cyclobenzaprine for the course of the study.
Key exclusion criteria (13 listed)
- Current or ongoing exposure to the trauma that resulted in the PTSD (ie, non-work-related trauma such as ongoing domestic abuse).
- 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 (eg, 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.
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 tabletsPatients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks | Drug | TNX-102 SL, 5.6 mg |
| PlaceboAlso: Placebo sublingual tabletsPatients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks | Drug | Placebo |
Primary outcome
Mean change from baseline in the total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.
Time frame: Day 1, Week 4, 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, fifth edition (CAPS-5) total symptom severity score in a 12-week study.
2 secondary outcomes
Clinical Global Impression - Severity change from Baseline to Week 12
Time frame: Day 1, Week 4, Week 8, Week 12
Change from baseline in the disruption of psychosocial functioning assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment.
Time frame: Day 1, Week 4, Week 8, Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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 Sullivan, MD study director
Tonix Pharmaceuticals
3 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 3 sites in Kenya.
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 10 inclusion and 13 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: withdrawn, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kenya. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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 1, Week 4, 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 11 Dec 2023.