PTSDPhase 3P306NCT03508700
A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
A Phase 3 study testing TNX-102 SL 5.6 mg in people with PTSD, run by Tonix Pharmaceuticals, Inc. at 16 sites in United States.
Trial summary
Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label extension study (TNX-CY-P303). 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 5.6 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 16 sitesUnited States
- Study dates
- 19 Apr 2018to 30 Sep 2019
- 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
- The patient has completed a double-blind lead-in HONOR study and a 12-week open-label extension study P303 and is judged by the investigator as reasonably compliant, with at least 60% compliance with study medication usage (based on drug accountability).
- The patient has provided written informed consent to participate in this extension study.
- The patient met all prior inclusion and exclusion requirements for the double-blind lead-in HONOR study, or the site received medical monitor approval for the patient to remain in the lead-in study after the retrospective discovery of an entry violation that did not pose any threat to the patient's safety or well-being.
- During the course of the lead-in HONOR study or 12-week open-label extension P303 study, the patient has had no intervening medical conditions including pregnancy, clinically significant increase in suicidal ideation (plan or intent) or significant worsening of depression, newly arising clinically significant abnormal laboratory tests, or any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the patient's ability to participate in the study or potentially compromise the patient's well-being during the study.
- The patient does not require treatment with a potent (strong) cytochrome P450 subtype 3A4 (CYP3A4) inhibitor, or St. John's wort.
- The patient is willing to refrain from use of all other formulations of cyclobenzaprine for the duration of the study.
- The patient is willing to refrain from use of monoamine oxidase inhibitors for the duration of the study.
- Female patients of childbearing potential continue to agree to practice one of the medically acceptable methods of birth control detailed in the lead-in study.
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Atlanta
Atlanta, Georgia, 30341
Beverly Hills
Beverly Hills, California, 90210
Canton
Canton, Ohio, 44718
Cedarhurst
Cedarhurst, New York, 11516
Cincinnati
Cincinnati, Ohio, 45219
Colorado Springs
Colorado Springs, Colorado, 80910
Las Vegas
Las Vegas, Nevada, 89102
Little Rock
Little Rock, Arkansas, 72211
New Bedford
New Bedford, Massachusetts, 02740
New York
New York, New York, 10128
Norwich
Norwich, Connecticut, 06360
Oceanside
Oceanside, California, 92056
Oklahoma City
Oklahoma City, Oklahoma, 73103
Orange
Orange, California, 92868
Tampa
Tampa, Florida, 33609
Temecula
Temecula, California, 92591
About this study
Official title: A 40-week Open-Label Extension Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label extension study (TNX-CY-P303).
Read the detailed description
This is an open-label, extension trial designed to evaluate safety over 40 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD.
The study will consist of 5 in-clinic study visits, including Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit of the 12-week open-label extension study TNX-CY-P303), followed by in-clinic visits after 7, 16, 28 and 40 weeks of open-label treatment.
- Conditions
- PTSD
- Being tested
- TNX-102 SL 5.6 mg
- Keywords
- TNX-102 SL, Bedtime, Sublingual, Safety, 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 SL 5.6 mgDrug
cyclobenzaprine HCl sublingual tablets
| Study group | Role | What they receive |
|---|---|---|
| TNX-102 SL 5.6 mg | Experimental | 2 tablets of TNX-102 SL 2.8 mg taken simultaneously and sublingually (under the tongue) each day at bedtime starting on Day 0 for 40 weeks Receives: Drug: TNX-102 SL 5.6 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Newly Emergent Adverse Events
Evaluate the incidence of newly emergent adverse events over an additional 40 weeks of treatment with TNX-102 SL 5.6 mg in patients with PTSD who have participated in a double-blinded lead-in study. Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class. Serious AEs and AEs leading to discontinuation of study drug will also be summarized.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start19 Apr 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label Study
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508700
- Sponsor's protocol ID
- TNX-CY-P306
- Acronym
- P306
- Status last verified
- Jan 2025
- First submitted
- 12 Apr 2018
- Last updated
- 5 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 40-week Open-Label Extension Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
- ClinicalTrials.gov ID
- NCT03508700
- Acronym / sponsor ID
- P306 / TNX-CY-P306
- Conditions
- PTSD
- Keywords
- TNX-102 SL, Bedtime, Sublingual, Safety, PTSD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Posted 5 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label extension study (TNX-CY-P303).
Detailed description
This is an open-label, extension trial designed to evaluate safety over 40 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD.
The study will consist of 5 in-clinic study visits, including Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit of the 12-week open-label extension study TNX-CY-P303), followed by in-clinic visits after 7, 16, 28 and 40 weeks of open-label treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label Study
| Arm | Type | Receives |
|---|---|---|
| TNX-102 SL 5.6 mg | Experimental | Drug: TNX-102 SL 5.6 mg2 tablets of TNX-102 SL 2.8 mg taken simultaneously and sublingually (under the tongue) each day at bedtime starting on Day 0 for 40 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient has completed a double-blind lead-in HONOR study and a 12-week open-label extension study P303 and is judged by the investigator as reasonably compliant, with at least 60% compliance with study medication usage (based on drug accountability).
- The patient has provided written informed consent to participate in this extension study.
- The patient met all prior inclusion and exclusion requirements for the double-blind lead-in HONOR study, or the site received medical monitor approval for the patient to remain in the lead-in study after the retrospective discovery of an entry violation that did not pose any threat to the patient's safety or well-being.
- During the course of the lead-in HONOR study or 12-week open-label extension P303 study, the patient has had no intervening medical conditions including pregnancy, clinically significant increase in suicidal ideation (plan or intent) or significant worsening of depression, newly arising clinically significant abnormal laboratory tests, or any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the patient's ability to participate in the study or potentially compromise the patient's well-being during the study.
- The patient does not require treatment with a potent (strong) cytochrome P450 subtype 3A4 (CYP3A4) inhibitor, or St. John's wort.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
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 SL 5.6 mgcyclobenzaprine HCl sublingual tablets | Drug | TNX-102 SL 5.6 mg |
Primary outcome
Incidence of Newly Emergent Adverse Events
Time frame: 40 weeks
Evaluate the incidence of newly emergent adverse events over an additional 40 weeks of treatment with TNX-102 SL 5.6 mg in patients with PTSD who have participated in a double-blinded lead-in study. Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class. Serious AEs and AEs leading to discontinuation of study drug will also be summarized.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 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 5.6 mg in people with PTSD, run by Tonix Pharmaceuticals, Inc. at 16 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 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 5 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 16 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 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 5 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?
Incidence of Newly Emergent Adverse Events (time frame: 40 weeks). 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 5 Feb 2025.