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

NCT ID: NCT02421679

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-14
• Study Completion Date: 2016-05-26

Brief Summary

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.

Detailed 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.

Conditions

PTSD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TNX-102 SL

TNX-102 SL taken daily at bedtime for 12 weeks

Group Type: EXPERIMENTAL

TNX-102 SL

Intervention Type: DRUG

1x 2.8mg TNX-102 SL Sublingual tablet

Interventions

TNX-102 SL

1x 2.8mg TNX-102 SL Sublingual tablet

Intervention Type: DRUG

Other Intervention Names

cyclobenzaprine HCI

Eligibility Criteria

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

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tonix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denise Bedoya

Role: STUDY_DIRECTOR

Premier Research Group plc

Locations

Tuscaloosa VA Medical Center

Tuscaloosa, Alabama, United States

Noesis Pharma

Phoenix, Arizona, United States

Sun Valley Research Center

Imperial, California, United States

Synergy Clinical Research

National City, California, United States

Excell Research, Inc

Oceanside, California, United States

Neuropsychiatric Research Center of Orange County

Orange, California, United States

CITRIALS

Riverside, California, United States

CESAMH

San Diego, California, United States

Cns, Inc.

Torrance, California, United States

Sarkis Clinical Trials

Lake City, Florida, United States

Compass Research North, LLC

Leesburg, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Atlanta Center For Medical Research

Atlanta, Georgia, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

Novex Clinical Research

New Bedford, Massachusetts, United States

Premier Psychiatric Research Institute, Inc.

Lincoln, Nebraska, United States

Altea Research

Las Vegas, Nevada, United States

Neurobehavioral Research, Inc.

Cedarhurst, New York, United States

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Clinical Trials of Texas

San Antonio, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Countries

United States

Other Identifiers

TNX-CY-P202

Identifier Type: -

Identifier Source: org_study_id