PTSD
Conditions
Keywords
TNX-102 SL, Bedtime, Sublingual, 3-month, Safety, Efficacy, PTSD
Brief summary
This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study.
Detailed description
The study will consist of 5 study visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit on double-blind treatment), a phone visit after 2 weeks of treatment, and in-clinic visits after 4, 8, and 12 weeks of treatment. The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study. The secondary objective of the study is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.
Interventions
DRUGTNX-102 SL
2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks
Sponsors
Premier Research
Tonix Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The patient has completed the final treatment study visit of the lead-in study and remained compliant with the lead-in protocol and study treatment. * The patient has provided written informed consent to participate in this extension protocol. * 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
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Newly Emergent Adverse Events of TNX-102 SL Tablets Taken Daily at Bedtime Over an Additional 12 Weeks in Patients With PTSD Who Have Completed a Double-blinded lead-in Study | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | Day 1 of TNX-CY-P301 (Week -12 of TNX-CY-P303), Day 1 of TNX-CY-P303, Week 12 of TNX-CY-P303 | The CAPS-5 symptom severity 1-week recall version will be administered by qualified and trained clinicians. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo - TNX-102 SL The patients in this group received placebo in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303. | 97 |
| TNX-102 SL - TNX-102 SL The patients in this group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303. | 93 |
| Total | 190 |
Baseline characteristics
| Characteristic | Placebo - TNX-102 SL | Total | TNX-102 SL - TNX-102 SL |
|---|---|---|---|
| Age, Continuous | 36.5 years STANDARD_DEVIATION 8.19 | 36.3 years STANDARD_DEVIATION 8.01 | 36.1 years STANDARD_DEVIATION 7.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 34 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 156 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 39 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) White | 64 Participants | 120 Participants | 56 Participants |
| Region of Enrollment United States | 97 participants | 190 participants | 93 participants |
| Sex: Female, Male Female | 15 Participants | 21 Participants | 6 Participants |
| Sex: Female, Male Male | 82 Participants | 169 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 93 |
| other Total, other adverse events | 49 / 97 | 19 / 93 |
| serious Total, serious adverse events | 0 / 97 | 0 / 93 |
Outcome results
Primary
Incidence of Newly Emergent Adverse Events of TNX-102 SL Tablets Taken Daily at Bedtime Over an Additional 12 Weeks in Patients With PTSD Who Have Completed 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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo - TNX-102 SL | Incidence of Newly Emergent Adverse Events of TNX-102 SL Tablets Taken Daily at Bedtime Over an Additional 12 Weeks in Patients With PTSD Who Have Completed a Double-blinded lead-in Study | 62 Participants |
| TNX-102 SL - TNX-102 SL | Incidence of Newly Emergent Adverse Events of TNX-102 SL Tablets Taken Daily at Bedtime Over an Additional 12 Weeks in Patients With PTSD Who Have Completed a Double-blinded lead-in Study | 40 Participants |
Secondary
Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score
The CAPS-5 symptom severity 1-week recall version will be administered by qualified and trained clinicians. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms.
Time frame: Day 1 of TNX-CY-P301 (Week -12 of TNX-CY-P303), Day 1 of TNX-CY-P303, Week 12 of TNX-CY-P303
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - TNX-102 SL | Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | Change from TNX-CY-P301 baseline | -24.5 units on a scale | Standard Error 2.43 |
| Placebo - TNX-102 SL | Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | Change from TNX-CY-P303 baseline | -6.2 units on a scale | Standard Error 1.63 |
| TNX-102 SL - TNX-102 SL | Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | Change from TNX-CY-P301 baseline | -24.2 units on a scale | Standard Error 2.64 |
| TNX-102 SL - TNX-102 SL | Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | Change from TNX-CY-P303 baseline | -6.2 units on a scale | Standard Error 1.78 |