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

Primary Purpose

PTSD

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TNX-102 SL 5.6 mg
Sponsored by
Tonix Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring TNX-102 SL, Bedtime, Sublingual, Safety, PTSD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Little Rock
  • Beverly Hills
  • Oceanside
  • Orange
  • Temecula
  • Colorado Springs
  • Norwich
  • Tampa
  • Atlanta
  • New Bedford
  • Las Vegas
  • Cedarhurst
  • New York
  • Canton
  • Cincinnati
  • Oklahoma City

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TNX-102 SL 5.6 mg

Arm Description

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

Outcomes

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
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
The CGI-I is a clinician-rated scale designed to assess overall clinical improvement (change) since baseline.

Full Information

First Posted
April 12, 2018
Last Updated
September 30, 2019
Sponsor
Tonix Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03508700
Brief Title
A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tonix Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
TNX-102 SL, Bedtime, Sublingual, Safety, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open-label Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNX-102 SL 5.6 mg
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
TNX-102 SL 5.6 mg
Intervention Description
cyclobenzaprine HCl sublingual tablets
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
40 weeks
Secondary Outcome Measure Information:
Title
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
Description
The CGI-I is a clinician-rated scale designed to assess overall clinical improvement (change) since baseline.
Time Frame
Weeks 7, 16, 28, and 40

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Little Rock
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Beverly Hills
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Oceanside
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Temecula
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Norwich
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
New Bedford
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Cedarhurst
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
New York
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Canton
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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