## Protocol Section
### Identification Module
**NCT ID:** NCT02421679

**Acronym:** P202

**Brief Title:** 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

#### Organization Study ID Info
**ID:** TNX-CY-P202
#### Organization
**Class:** INDUSTRY
**Full Name:** Tonix Pharmaceuticals, Inc.
### Status Module
#### Completion Date
**Date:** 2016-08

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2017-10-31

**Type:** ACTUAL

**Disp First Submit Date:** 2017-10-26
**Disp First Submit QC Date:** 2017-10-26

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-10-31

**Type:** ACTUAL

**Last Update Submit Date:** 2017-10-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-08

**Type:** ACTUAL

#### Start Date
**Date:** 2015-04

**Type:** ACTUAL

**Status Verified Date:** 2017-10

#### Study First Post Date
**Date:** 2015-04-21
**Type:** ESTIMATED
**Study First Submit Date:** 2015-04-09
**Study First Submit QC Date:** 2015-04-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Tonix Pharmaceuticals, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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). 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.

### Conditions Module

**Conditions:**

- PTSD

**Keywords:**

- PTSD

- Military-related PTSD and other related conditions

- open-label extension

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 159

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** TNX-102 SL taken daily at bedtime for 12 weeks

**Intervention Names:**

- Drug: TNX-102 SL

**Label:** TNX-102 SL

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TNX-102 SL

**Description:** TNX-102 Sublingual tablets

**Name:** TNX-102 SL

**Other Names:**

- cyclobenzaprine HCI

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** To evaluate the safety of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) as new treatment emergent AEs since lead-in study, change in clinical laboratory test results and vital signs

**Measure:** Safety (Adverse events, change in lab test results and vital signs)

**Time Frame:** Week 12

#### Secondary Outcomes

**Description:** Changes in total CAPS-5 score from baseline in lead-in study and since baseline in this study

**Measure:** Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5)

**Time Frame:** Weeks 2, 6 and 12

**Description:** ≥30% decrease in Total CAPS-5 score at weeks from baseline in lead-in study and since baseline in this study

**Measure:** Response rates a in Total CAPS-5 score

**Time Frame:** Weeks 2, 6 and 12

**Description:** Changes from baseline in lead-in study and since baseline in this study in item scores, including

* intrusion symptoms (Criterion B)
* CAPS-5 item 2. (B-2) (unpleasant dreams related to the trauma)
* persistent avoidance (Criterion C),
* negative cognitions and mood (Criterion D)
* arousal and reactivity (Criterion E)

**Measure:** CAPS-5 cluster score items

**Time Frame:** Weeks 2, 6 and 12

**Description:** Changes from baseline in lead-in study and since baseline in this study in MADRS

**Measure:** Montgomery-Asberg Depression Rating Scale

**Time Frame:** Week 12

**Description:** Changes from baseline in lead-in study and since baseline in this study in PROMIS scores

**Measure:** PROMIS (Patient -Reported Outcome Measurement Information System)

**Time Frame:** Week 12

**Description:** Changes from baseline in lead-in study and since baseline in this study in MTRSS scores

**Measure:** MTRSS (Morning Treatment-Related Sedation Scale)

**Time Frame:** Week 12

**Description:** Changes from baseline in lead-in study and since baseline in this study in PGIC

**Measure:** PGIC (Patient Global Impression of Change Scale)

**Time Frame:** Week 12

### Eligibility Module

**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

**Maximum Age:** 66 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tuscaloosa

**Country:** United States

**Facility:** Tuscaloosa VA Medical Center

**State:** Alabama

**Zip:** 35404

**Location 2:**

**City:** Phoenix

**Country:** United States

**Facility:** Noesis Pharma

**State:** Arizona

**Zip:** 85032

**Location 3:**

**City:** Imperial

**Country:** United States

**Facility:** Sun Valley Reserach Center

**State:** California

**Zip:** 92251

**Location 4:**

**City:** National City

**Country:** United States

**Facility:** Synergy Clinical Research

**State:** California

**Zip:** 91950

**Location 5:**

**City:** Oceanside

**Country:** United States

**Facility:** Excell Research, Inc

**State:** California

**Zip:** 92506

**Location 6:**

**City:** Orange

**Country:** United States

**Facility:** Neuropsychiatric Research Center of Orange County

**State:** California

**Zip:** 92868

**Location 7:**

**City:** Riverside

**Country:** United States

**Facility:** CITRIALS

**State:** California

**Zip:** 92506

**Location 8:**

**City:** San Diego

**Country:** United States

**Facility:** CESAMH

**State:** California

**Zip:** 92103

**Location 9:**

**City:** Torrance

**Country:** United States

**Facility:** Cns, Inc.

**State:** California

**Zip:** 90502

**Location 10:**

**City:** Lake City

**Country:** United States

**Facility:** Sarkis Clinical Trials

**State:** Florida

**Zip:** 32025

**Location 11:**

**City:** Leesburg

**Country:** United States

**Facility:** Compass Research North, LLC

**State:** Florida

**Zip:** 34748

**Location 12:**

**City:** Orlando

**Country:** United States

**Facility:** Clinical Neuroscience Solutions, Inc.

**State:** Florida

**Zip:** 32801

**Location 13:**

**City:** Atlanta

**Country:** United States

**Facility:** Atlanta Center For Medical Research

**State:** Georgia

**Zip:** 30308

**Location 14:**

**City:** Chicago

**Country:** United States

**Facility:** Great Lakes Clinical Trials

**State:** Illinois

**Zip:** 60640

**Location 15:**

**City:** New Bedford

**Country:** United States

**Facility:** Novex Clinical Research

**State:** Massachusetts

**Zip:** 02740

**Location 16:**

**City:** Lincoln

**Country:** United States

**Facility:** Premier Psychiatric Research Instititute, Inc.

**State:** Nebraska

**Zip:** 68526

**Location 17:**

**City:** Las Vegas

**Country:** United States

**Facility:** Altea Research

**State:** Nevada

**Zip:** 89102

**Location 18:**

**City:** Cedarhurst

**Country:** United States

**Facility:** Neurobehavioral Research, Inc.

**State:** New York

**Zip:** 11516

**Location 19:**

**City:** Cincinnati

**Country:** United States

**Facility:** University of Cincinnati College of Medicine

**State:** Ohio

**Zip:** 45219

**Location 20:**

**City:** Cleveland

**Country:** United States

**Facility:** University Hospitals Case Medical Center

**State:** Ohio

**Zip:** 44106

**Location 21:**

**City:** San Antonio

**Country:** United States

**Facility:** Clinical Trials of Texas

**State:** Texas

**Zip:** 78229

**Location 22:**

**City:** Bellevue

**Country:** United States

**Facility:** Northwest Clinical Research Center

**State:** Washington

**Zip:** 98007

#### Overall Officials

**Official 1:**

**Affiliation:** Premier Research Group plc

**Name:** Denise Bedoya

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000040921

- Term: Stress Disorders, Traumatic

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M16103

- Name: Stress Disorders, Post-Traumatic

- Relevance: HIGH

- As Found: PTSD

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004194

- Term: Disease

- ID: D000013313

- Term: Stress Disorders, Post-Traumatic

### Intervention Browse Module - Ancestors

- ID: D000000929

- Term: Antidepressive Agents, Tricyclic

- ID: D000000928

- Term: Antidepressive Agents

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000009125

- Term: Muscle Relaxants, Central

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000009465

- Term: Neuromuscular Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: MuRelCen

- Name: Muscle Relaxants, Central

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M228188

- Name: Cyclobenzaprine

- Relevance: HIGH

- As Found: Vortioxetine

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4248

- Name: Antidepressive Agents, Tricyclic

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000004704

- Term: Cyclobenzaprine

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2024-04-30

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2024-04-30

- Reset Date: Unknown

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
