Clinical trial NCT03110575: 12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
Official title: A 12-Week Open-Label Extension Study to Evaluate TNX-102 SL Taken Daily at Bedtime in Patients With PTSD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: PTSD
Keywords: TNX-102 SL
Bedtime
Sublingual
3-month
Safety
Efficacy
PTSD
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2017-04-12
Enrollment: 190
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
Primary purpose: TREATMENT

Brief summary: This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study.

Detailed description: The study will consist of 5 study visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit on double-blind treatment), a phone visit after 2 weeks of treatment, and in-clinic visits after 4, 8, and 12 weeks of treatment.

The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.

The secondary objective of the study is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.

Eligibility criteria: Inclusion Criteria:

* The patient has completed the final treatment study visit of the lead-in study and remained compliant with the lead-in protocol and study treatment.
* The patient has provided written informed consent to participate in this extension protocol.
* 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:

* None.

Primary outcomes:
measure: Incidence of Newly Emergent Adverse Events of TNX-102 SL Tablets Taken Daily at Bedtime Over an Additional 12 Weeks in Patients With PTSD Who Have Completed a Double-blinded lead-in Study
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score
timeFrame: Day 1 of TNX-CY-P301 (Week -12 of TNX-CY-P303), Day 1 of TNX-CY-P303, Week 12 of TNX-CY-P303
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix
state: Arizona
city: Rogers
country: United States
facility: Rogers
state: Arkansas
city: Beverly Hills
country: United States
facility: Beverly Hills
state: California
city: Glendale
country: United States
facility: Glendale
state: California
city: Oakland
country: United States
facility: Oakland
state: California
city: Oceanside
country: United States
facility: Oceanside
state: California
city: Orange
country: United States
facility: Orange
state: California
city: Riverside
country: United States
facility: Riverside
state: California
city: San Diego
country: United States
facility: San Diego
state: California
city: San Diego
country: United States
facility: San Diego
state: California
city: Temecula
country: United States
facility: Temecula
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs
state: Colorado
city: Jacksonville
country: United States
facility: Jacksonville
state: Florida
city: Lake City
country: United States
facility: Lake City
state: Florida
city: Lauderhill
country: United States
facility: Lauderhill
state: Florida
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: Flowood
country: United States
facility: Flowood
state: Mississippi
city: Las Vegas
country: United States
facility: Las Vegas
state: Nevada
city: Berlin
country: United States
facility: Berlin
state: New Jersey
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: Dayton
country: United States
facility: Dayton
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City
state: Oklahoma
city: Charleston
country: United States
facility: Charleston
state: South Carolina
city: Austin
country: United States
facility: Austin
state: Texas
city: Dallas
country: United States
facility: Dallas
state: Texas
city: Houston
country: United States
facility: Houston
state: Texas
city: San Antonio
country: United States
facility: San Antonio
state: Texas
Study officials:
affiliation: Premier Research Group plc
name: Denise Bedoya
role: STUDY_DIRECTOR
References: