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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03508700
Recruitment Status : Completed
First Posted : April 26, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE April 26, 2018
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE April 19, 2018
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2018)
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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2018)
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 [ Time Frame: Weeks 7, 16, 28, and 40 ]
The CGI-I is a clinician-rated scale designed to assess overall clinical improvement (change) since baseline.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
Official Title  ICMJE A 40-week Open-Label Extension Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open-label Study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE Drug: TNX-102 SL 5.6 mg
cyclobenzaprine HCl sublingual tablets
Study Arms  ICMJE 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
Intervention: Drug: TNX-102 SL 5.6 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2019)
93
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2018)
200
Actual Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03508700
Other Study ID Numbers  ICMJE TNX-CY-P306
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Tonix Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tonix Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tonix Pharmaceuticals, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP