A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD

PTSD Clinical Trial

— P306  

Official title:

A 40-week Open-Label Extension Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508700
• Other study ID #: TNX-CY-P306
• Status: Completed
• Phase: Phase 3
• Start date: April 19, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2019
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label extension study (TNX-CY-P303).

Description:

This is an open-label, extension trial designed to evaluate safety over 40 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD.

The study will consist of 5 in-clinic study visits, including Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit of the 12-week open-label extension study TNX-CY-P303), followed by in-clinic visits after 7, 16, 28 and 40 weeks of open-label treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The patient has completed a double-blind lead-in HONOR study and a 12-week open-label extension study P303 and is judged by the investigator as reasonably compliant, with at least 60% compliance with study medication usage (based on drug accountability).

• The patient has provided written informed consent to participate in this extension study.

• The patient met all prior inclusion and exclusion requirements for the double-blind lead-in HONOR study, or the site received medical monitor approval for the patient to remain in the lead-in study after the retrospective discovery of an entry violation that did not pose any threat to the patient's safety or well-being.

• During the course of the lead-in HONOR study or 12-week open-label extension P303 study, the patient has had no intervening medical conditions including pregnancy, clinically significant increase in suicidal ideation (plan or intent) or significant worsening of depression, newly arising clinically significant abnormal laboratory tests, or any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the patient's ability to participate in the study or potentially compromise the patient's well-being during the study.

• The patient does not require treatment with a potent (strong) cytochrome P450 subtype 3A4 (CYP3A4) inhibitor, or St. John's wort.

• The patient is willing to refrain from use of all other formulations of cyclobenzaprine for the duration of the study.

• The patient is willing to refrain from use of monoamine oxidase inhibitors for the duration of the study.

• 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:

• There are no exclusion criteria for this study.

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Drug:
• TNX-102 SL 5.6 mg
cyclobenzaprine HCl sublingual tablets

Locations

Country	Name	City	State
United States	Atlanta	Atlanta	Georgia
United States	Beverly Hills	Beverly Hills	California
United States	Canton	Canton	Ohio
United States	Cedarhurst	Cedarhurst	New York
United States	Cincinnati	Cincinnati	Ohio
United States	Colorado Springs	Colorado Springs	Colorado
United States	Las Vegas	Las Vegas	Nevada
United States	Little Rock	Little Rock	Arkansas
United States	New Bedford	New Bedford	Massachusetts
United States	New York	New York	New York
United States	Norwich	Norwich	Connecticut
United States	Oceanside	Oceanside	California
United States	Oklahoma City	Oklahoma City	Oklahoma
United States	Orange	Orange	California
United States	Tampa	Tampa	Florida
United States	Temecula	Temecula	California

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	Evaluate the incidence of adverse events of TNX-102 SL tablets taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in 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. Serious AEs and AEs leading to discontinuation of study drug will also be summarized.	40 weeks
Secondary	Evaluate the proportion of patients with a CGI-I score of "very much improved" or "much improved" of TNX-102 SL tablets taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blinded lead-in study	The CGI-I is a clinician-rated scale designed to assess overall clinical improvement (change) since baseline.	Weeks 7, 16, 28, and 40