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

PTSD Clinical Trial

Official title:

A 12-Week Open-Label Extension Study to Evaluate TNX-102 SL Taken Daily at Bedtime in Patients With PTSD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03110575
• Other study ID #: TNX-CY-P303
• Status: Terminated
• Phase: Phase 3
• Start date: June 20, 2017
• Est. completion date: July 27, 2018

Study information

• Verified date: September 2019
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 189
• Est. completion date: July 27, 2018
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Drug:
• TNX-102 SL
2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks

Locations

Country	Name	City	State
United States	Atlanta	Atlanta	Georgia
United States	Austin	Austin	Texas
United States	Berlin	Berlin	New Jersey
United States	Beverly Hills	Beverly Hills	California
United States	Canton	Canton	Ohio
United States	Cedarhurst	Cedarhurst	New York
United States	Charleston	Charleston	South Carolina
United States	Cincinnati	Cincinnati	Ohio
United States	Colorado Springs	Colorado Springs	Colorado
United States	Dallas	Dallas	Texas
United States	Dayton	Dayton	Ohio
United States	Flowood	Flowood	Mississippi
United States	Glendale	Glendale	California
United States	Houston	Houston	Texas
United States	Jacksonville	Jacksonville	Florida
United States	Lake City	Lake City	Florida
United States	Las Vegas	Las Vegas	Nevada
United States	Lauderhill	Lauderhill	Florida
United States	New Bedford	New Bedford	Massachusetts
United States	New York	New York	New York
United States	Oakland	Oakland	California
United States	Oceanside	Oceanside	California
United States	Oklahoma City	Oklahoma City	Oklahoma
United States	Orange	Orange	California
United States	Phoenix	Phoenix	Arizona
United States	Riverside	Riverside	California
United States	Rogers	Rogers	Arkansas
United States	San Antonio	San Antonio	Texas
United States	San Diego	San Diego	California
United States	San Diego	San Diego	California
United States	Tampa	Tampa	Florida
United States	Temecula	Temecula	California

Sponsors (2)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.	Premier Research Group plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 weeks
Secondary	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	The CAPS-5 symptom severity 1-week recall version will be administered by qualified and trained clinicians.	Week 0, 12
Secondary	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	The CGI-I is a clinician-rated scale designed to assess overall clinical improvement (change) since baseline.	Week 4, 8, 12