Clinical trial NCT03508700: A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: PTSD
Keywords: TNX-102 SL
Bedtime
Sublingual
Safety
PTSD
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-26
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label Study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of Newly Emergent Adverse Events
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock
state: Arkansas
city: Beverly Hills
country: United States
facility: Beverly Hills
state: California
city: Oceanside
country: United States
facility: Oceanside
state: California
city: Orange
country: United States
facility: Orange
state: California
city: Temecula
country: United States
facility: Temecula
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs
state: Colorado
city: Norwich
country: United States
facility: Norwich
state: Connecticut
city: Tampa
country: United States
facility: Tampa
state: Florida
city: Atlanta
country: United States
facility: Atlanta
state: Georgia
city: New Bedford
country: United States
facility: New Bedford
state: Massachusetts
city: Las Vegas
country: United States
facility: Las Vegas
state: Nevada
city: Cedarhurst
country: United States
facility: Cedarhurst
state: New York
city: New York
country: United States
facility: New York
state: New York
city: Canton
country: United States
facility: Canton
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City
state: Oklahoma
Study officials:
References: