12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients

Phase 3

Terminated

• Conditions: PTSD
• Interventions: Drug: TNX-102 SL

• Registration Number: NCT03110575
• Lead Sponsor: Tonix Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Study Start: 2017-06-20
• Primary Completion: 2018-07-27
• Study Completion: 2018-07-27
• Status Verified: 2019-09
• Disposition First Submitted: 2019-09-09
• Disposition First Submitted QC: 2019-09-09
• Last Update Submitted: 2019-09-09
• Disposition First Posted: 2019-09-17
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 189

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.

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Exclusion Criteria

• None.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TNX-102 SL	TNX-102 SL	2 x TNX-102 SL, 2.8 mg tablets taken daily at bedtime for 12 weeks

Primary Outcome Measures

Name	Time	Method
Evaluate the incidence of 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	12 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

Name	Time	Method
Evaluate the change from both baselines in the Total CAPS-5 score 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	Week 0, 12	The CAPS-5 symptom severity 1-week recall version will be administered by qualified and trained clinicians.
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 12 weeks in patients with PTSD who have completed a double-blinded lead-in study	Week 4, 8, 12	The CGI-I is a clinician-rated scale designed to assess overall clinical improvement (change) since baseline.

Trial Locations

Locations (31)

New York; 🇺🇸 New York, New York, United States

Orange; 🇺🇸 Orange, California, United States

Rogers; 🇺🇸 Rogers, Arkansas, United States

Phoenix; 🇺🇸 Phoenix, Arizona, United States

Atlanta; 🇺🇸 Atlanta, Georgia, United States

New Bedford; 🇺🇸 New Bedford, Massachusetts, United States

Dallas; 🇺🇸 Dallas, Texas, United States

Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Flowood; 🇺🇸 Flowood, Mississippi, United States

San Diego; 🇺🇸 San Diego, California, United States

Lake City; 🇺🇸 Lake City, Florida, United States

Berlin; 🇺🇸 Berlin, New Jersey, United States

Cedarhurst; 🇺🇸 Cedarhurst, New York, United States

Charleston; 🇺🇸 Charleston, South Carolina, United States

Austin; 🇺🇸 Austin, Texas, United States

San Antonio; 🇺🇸 San Antonio, Texas, United States

Oakland; 🇺🇸 Oakland, California, United States

Glendale; 🇺🇸 Glendale, California, United States

Beverly Hills; 🇺🇸 Beverly Hills, California, United States

Riverside; 🇺🇸 Riverside, California, United States

Oceanside; 🇺🇸 Oceanside, California, United States

Lauderhill; 🇺🇸 Lauderhill, Florida, United States

Tampa; 🇺🇸 Tampa, Florida, United States

Temecula; 🇺🇸 Temecula, California, United States

Colorado Springs; 🇺🇸 Colorado Springs, Colorado, United States

Canton; 🇺🇸 Canton, Ohio, United States

Dayton; 🇺🇸 Dayton, Ohio, United States

Houston; 🇺🇸 Houston, Texas, United States

Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

Oklahoma City; 🇺🇸 Oklahoma City, Oklahoma, United States