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

PTSD Clinical Trial

— P202  

Official title:

A 12-Week, Open-Label, Multicenter, Extension Study To TNX-CY-P201 To Evaluate The Safety And Efficacy Of TNX-102 SL Taken Daily At Bedtime In Patients With Military-Related PTSD And Related Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421679
• Other study ID #: TNX-CY-P202
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2015
• Last updated: October 26, 2017
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2017
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). Patients will not be made aware of the therapy they received during the double-blind study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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:

Related Conditions & MeSH terms

• PTSD

Intervention

Drug:
• TNX-102 SL
TNX-102 Sublingual tablets

Locations

Country	Name	City	State
United States	Atlanta Center For Medical Research	Atlanta	Georgia
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Sun Valley Reserach Center	Imperial	California
United States	Sarkis Clinical Trials	Lake City	Florida
United States	Altea Research	Las Vegas	Nevada
United States	Compass Research North, LLC	Leesburg	Florida
United States	Premier Psychiatric Research Instititute, Inc.	Lincoln	Nebraska
United States	Synergy Clinical Research	National City	California
United States	Novex Clinical Research	New Bedford	Massachusetts
United States	Excell Research, Inc	Oceanside	California
United States	Neuropsychiatric Research Center of Orange County	Orange	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Noesis Pharma	Phoenix	Arizona
United States	CITRIALS	Riverside	California
United States	Clinical Trials of Texas	San Antonio	Texas
United States	CESAMH	San Diego	California
United States	Cns, Inc.	Torrance	California
United States	Tuscaloosa VA Medical Center	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Adverse events, change in lab test results and vital signs)	To evaluate the safety of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) as new treatment emergent AEs since lead-in study, change in clinical laboratory test results and vital signs	Week 12
Secondary	Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5)	Changes in total CAPS-5 score from baseline in lead-in study and since baseline in this study	Weeks 2, 6 and 12
Secondary	Response rates a in Total CAPS-5 score	=30% decrease in Total CAPS-5 score at weeks from baseline in lead-in study and since baseline in this study	Weeks 2, 6 and 12
Secondary	CAPS-5 cluster score items	Changes from baseline in lead-in study and since baseline in this study in item scores, including; intrusion symptoms (Criterion B); CAPS-5 item 2. (B-2) (unpleasant dreams related to the trauma); persistent avoidance (Criterion C),; negative cognitions and mood (Criterion D); arousal and reactivity (Criterion E)	Weeks 2, 6 and 12
Secondary	Montgomery-Asberg Depression Rating Scale	Changes from baseline in lead-in study and since baseline in this study in MADRS	Week 12
Secondary	PROMIS (Patient -Reported Outcome Measurement Information System)	Changes from baseline in lead-in study and since baseline in this study in PROMIS scores	Week 12
Secondary	MTRSS (Morning Treatment-Related Sedation Scale)	Changes from baseline in lead-in study and since baseline in this study in MTRSS scores	Week 12
Secondary	PGIC (Patient Global Impression of Change Scale)	Changes from baseline in lead-in study and since baseline in this study in PGIC	Week 12