P306: A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD

Sponsor

Tonix Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03508700

Collaborator

(none)

Enrollment

Locations

Arm

17.4

Actual Duration (Months)

5.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
PTSD	Drug: TNX-102 SL 5.6 mg	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

93 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open-label StudyOpen-label Study

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 19, 2018

Actual Primary Completion Date :

Sep 30, 2019

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TNX-102 SL 5.6 mg 2 tablets of TNX-102 SL 2.8 mg taken simultaneously and sublingually (under the tongue) each day at bedtime starting on Day 0 for 40 weeks	Drug: TNX-102 SL 5.6 mg cyclobenzaprine HCl sublingual tablets

Arm

Intervention/Treatment

Experimental: TNX-102 SL 5.6 mg

2 tablets of TNX-102 SL 2.8 mg taken simultaneously and sublingually (under the tongue) each day at bedtime starting on Day 0 for 40 weeks

Drug: TNX-102 SL 5.6 mg

cyclobenzaprine HCl sublingual tablets

Outcome Measures

Primary Outcome Measures

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 [40 weeks]
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.

Secondary Outcome Measures

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 [Weeks 7, 16, 28, and 40]
The CGI-I is a clinician-rated scale designed to assess overall clinical improvement (change) since baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Little Rock	Little Rock	Arkansas	United States	72211
2	Beverly Hills	Beverly Hills	California	United States	90210
3	Oceanside	Oceanside	California	United States	92056
4	Orange	Orange	California	United States	92868
5	Temecula	Temecula	California	United States	92591
6	Colorado Springs	Colorado Springs	Colorado	United States	80910
7	Norwich	Norwich	Connecticut	United States	06360
8	Tampa	Tampa	Florida	United States	33609
9	Atlanta	Atlanta	Georgia	United States	30341
10	New Bedford	New Bedford	Massachusetts	United States	02740
11	Las Vegas	Las Vegas	Nevada	United States	89102
12	Cedarhurst	Cedarhurst	New York	United States	11516
13	New York	New York	New York	United States	10128
14	Canton	Canton	Ohio	United States	44718
15	Cincinnati	Cincinnati	Ohio	United States	45219
16	Oklahoma City	Oklahoma City	Oklahoma	United States	73103