Primary Fibromyalgia
Conditions
Keywords
TNX-102 SL, bedtime, sublingual, 3-month, long term safety, long term efficacy, Fibromyalgia
Brief summary
This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302. Patients will not be made aware of the therapy they received during the double-blind study.
Detailed description
The study consist of 4 study visits, including Screening/Baseline Visit 1 (Day 1, which is anticipated to be the same date as Visit 6 in F301 or F302) and visits after 1, 2 and 3 months of treatment (Visits 2-4). Primary: The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 3 months in patients with FM who have completed the double-blinded lead-in study Secondary: The secondary objective is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of FM
Interventions
DRUGTNX-102 SL Tablet 2.8 mg
TNX-102 SL 2.8 mg tablet taken daily at bedtime
Sponsors
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 met all prior inclusion and exclusion requirements for study F301 or F302 originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the extension study. * The patient completed expected dosing in F301 or F302 defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on overall drug accountability reconciliation at the end of the F301 or F302 lead-in study) and no major protocol deviations. * The patient has provided written informed consent to participate in this extension protocol.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Newly Emergent Adverse Events | Up to 3 months from first dose | The number of patients with at least one adverse event which began after the first dose of TNX-102 SL in this open-label extension study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TNX-TNX This group received 1x 2.8 mg TNX-102 SL sublingual tablet daily in the lead in study TNX-CY-F301, then continued to receive 1x 2.8 mg TNX-102 SL sublingual tablet in this open-label extension study. | 177 |
| PBO-TNX This group received 1x Placebo sublingual tablet daily in the lead in study TNX-CY-F301, then received 1x 2.8 mg TNX-102 SL sublingual tablet in this open-label extension study. | 198 |
| Total | 375 |
Baseline characteristics
| Characteristic | TNX-TNX | Total | PBO-TNX |
|---|---|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 11.35 | 48.1 years STANDARD_DEVIATION 11.03 | 48.0 years STANDARD_DEVIATION 10.77 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 25 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 166 Participants | 338 Participants | 172 Participants |
| Region of Enrollment United States | 177 participants | 375 participants | 198 participants |
| Sex: Female, Male Female | 169 Participants | 360 Participants | 191 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 177 | 0 / 198 |
| other Total, other adverse events | 69 / 170 | 86 / 186 |
| serious Total, serious adverse events | 2 / 170 | 0 / 186 |
Outcome results
Primary
Newly Emergent Adverse Events
The number of patients with at least one adverse event which began after the first dose of TNX-102 SL in this open-label extension study.
Time frame: Up to 3 months from first dose
Population: Data is reported for all patients with AE data collected at the time when this study was terminated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TNX-TNX | Newly Emergent Adverse Events | 77 Participants |
| PBO-TNX | Newly Emergent Adverse Events | 132 Participants |