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Trial record 38 of 47 for:    CYCLOBENZAPRINE

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.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-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 : April 19, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508700


Locations
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United States, Arkansas
Little Rock
Little Rock, Arkansas, United States, 72211
United States, California
Beverly Hills
Beverly Hills, California, United States, 90210
Oceanside
Oceanside, California, United States, 92056
Orange
Orange, California, United States, 92868
Temecula
Temecula, California, United States, 92591
United States, Colorado
Colorado Springs
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Norwich
Norwich, Connecticut, United States, 06360
United States, Florida
Tampa
Tampa, Florida, United States, 33609
United States, Georgia
Atlanta
Atlanta, Georgia, United States, 30341
United States, Massachusetts
New Bedford
New Bedford, Massachusetts, United States, 02740
United States, Nevada
Las Vegas
Las Vegas, Nevada, United States, 89102
United States, New York
Cedarhurst
Cedarhurst, New York, United States, 11516
New York
New York, New York, United States, 10128
United States, Ohio
Canton
Canton, Ohio, United States, 44718
Cincinnati
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Oklahoma City
Oklahoma City, Oklahoma, United States, 73103
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.

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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03508700     History of Changes
Other Study ID Numbers: TNX-CY-P306
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tonix Pharmaceuticals, Inc.:
TNX-102 SL
Bedtime
Sublingual
Safety
PTSD
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders