Clinical trial NCT02421679: Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
Official title: A 12-Week, Open-Label, Multicenter, Extension Study To TNX-CY-P201 To Evaluate The Safety And Efficacy Of TNX-102 SL Taken Daily At Bedtime In Patients With Military-Related PTSD And Related Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PTSD
Keywords: PTSD
Military-related PTSD and other related conditions
open-label extension
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-21
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-P201 (AtEase Study) \[NCT02277704\]. Patients will not be made aware of the therapy they received during the double-blind study.

Detailed description: The study will consist of 4 clinic visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as the final visit in the lead-in P201 study) and visits after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for refraining from the use of certain concomitant medications and trauma-focused psychotherapies will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or they may utilize other medications as needed to help them sleep, per the judgment of the investigator.

Eligible patients who provide written informed consent will take one TNX-102 SL tablet daily at bedtime sublingually (under the tongue) for 12 weeks. All patients will be assigned to receive tthe same dosage of TNX-102 SL, regardless of their treatment assignment in the lead-in study. No patients, investigators, or study staff will know the assigned study treatment from the lead-in study, P201, at the time of entry into the extension study. Patient data collected at the Week 12 visit (Visit 9) in the lead-in P201 study will be used as one of the baseline values for this study.

Eligibility criteria: Inclusion Criteria:

* Completed the lead-in study and is judged as reasonably compliant, with at least 60% compliance
* Signed informed consent
* Met all prior inclusion and exclusion requirements for lead-in study
* No new or worsening medical conditions since starting the lead-in study that could pose a safety risk or interfere with participation in the study
* Willing to refrain from use of specific medication (ask PI)
* Female patients of childbearing potential continue to practice medically acceptable methods of birth control

Exclusion Criteria:

* None

Primary outcomes:
measure: Newly Treatment Emergent Adverse Events
timeFrame: Week 12
Secondary outcomes:
measure: Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5)
timeFrame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
measure: Response Rates a in Total CAPS-5 Score
timeFrame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P201 Week 12
measure: CAPS-5 Cluster Score Items
timeFrame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
measure: Montgomery-Asberg Depression Rating Scale
timeFrame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
measure: PROMIS (Patient -Reported Outcome Measurement Information System)
timeFrame: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Noesis Pharma
state: Arizona
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: National City
country: United States
facility: Synergy Clinical Research
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Riverside
country: United States
facility: CITRIALS
state: California
city: San Diego
country: United States
facility: CESAMH
state: California
city: Torrance
country: United States
facility: Cns, Inc.
state: California
city: Lake City
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Leesburg
country: United States
facility: Compass Research North, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center For Medical Research
state: Georgia
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: New Bedford
country: United States
facility: Novex Clinical Research
state: Massachusetts
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: Altea Research
state: Nevada
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Premier Research Group plc
name: Denise Bedoya
role: STUDY_DIRECTOR
References: