Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions (P202)

Tonix Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

PTSD

Treatments

Drug: TNX-102 SL

Study type

Interventional

Funder types

Industry

Identifiers

NCT02421679

TNX-CY-P202

Details and patient eligibility

About

This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-P201 (AtEase Study) [NCT02277704]. Patients will not be made aware of the therapy they received during the double-blind study.

Full description

The study will consist of 4 clinic visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as the final visit in the lead-in P201 study) and visits after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for refraining from the use of certain concomitant medications and trauma-focused psychotherapies will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or they may utilize other medications as needed to help them sleep, per the judgment of the investigator.

Eligible patients who provide written informed consent will take one TNX-102 SL tablet daily at bedtime sublingually (under the tongue) for 12 weeks. All patients will be assigned to receive tthe same dosage of TNX-102 SL, regardless of their treatment assignment in the lead-in study. No patients, investigators, or study staff will know the assigned study treatment from the lead-in study, P201, at the time of entry into the extension study. Patient data collected at the Week 12 visit (Visit 9) in the lead-in P201 study will be used as one of the baseline values for this study.

Enrollment

159 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Completed the lead-in study and is judged as reasonably compliant, with at least 60% compliance
Signed informed consent
Met all prior inclusion and exclusion requirements for lead-in study
No new or worsening medical conditions since starting the lead-in study that could pose a safety risk or interfere with participation in the study
Willing to refrain from use of specific medication (ask PI)
Female patients of childbearing potential continue to practice medically acceptable methods of birth control

Exclusion criteria