PTSD
Conditions
Keywords
TNX-102 SL, Bedtime, Sublingual, Safety, PTSD
Brief 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).
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.
Interventions
cyclobenzaprine HCl sublingual tablets
Sponsors
Tonix Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Newly Emergent Adverse Events | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo - TNX-102 SL This group received placebo in the lead-in double blind study TNX-CY-P301, and received TNX-102-SL 5.6 mg in this open label study TNX-CY-P306. | 49 |
| TNX-102 SL - TNX-102 SL This group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, and received TNX-102 SL 5.6mg in this open label study TNX-CY-P306. | 44 |
| Total | 93 |
Baseline characteristics
| Characteristic | TNX-102 SL - TNX-102 SL | Total | Placebo - TNX-102 SL |
|---|---|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 7.91 | 36.8 years STANDARD_DEVIATION 8.89 | 38.8 years STANDARD_DEVIATION 9.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 11 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 82 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 18 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 57 Participants | 31 Participants |
| Region of Enrollment United States | 44 participants | 93 participants | 49 participants |
| Sex: Female, Male Female | 3 Participants | 11 Participants | 8 Participants |
| Sex: Female, Male Male | 41 Participants | 82 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 44 |
| other Total, other adverse events | 6 / 49 | 2 / 44 |
| serious Total, serious adverse events | 0 / 49 | 0 / 44 |
Outcome results
Primary
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.
Time frame: 40 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo - TNX-102 SL | Incidence of Newly Emergent Adverse Events | 26 Participants |
| TNX-102 SL - TNX-102 SL | Incidence of Newly Emergent Adverse Events | 19 Participants |