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

Sponsor

Tonix Pharmaceuticals, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT03110575

Collaborator

Premier Research Group plc (Industry)

189

Enrollment

Locations

Arm

13.2

Actual Duration (Months)

5.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PTSD	Drug: TNX-102 SL	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

189 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 20, 2017

Actual Primary Completion Date :

Jul 27, 2018

Actual Study Completion Date :

Jul 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TNX-102 SL 2 x TNX-102 SL, 2.8 mg tablets taken daily at bedtime for 12 weeks	Drug: TNX-102 SL 2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks Other Names: cyclobenzaprine HCl

Arm

Intervention/Treatment

Experimental: TNX-102 SL

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

Drug: TNX-102 SL

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

Other Names:

cyclobenzaprine HCl

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix	Phoenix	Arizona	United States	85032
2	Rogers	Rogers	Arkansas	United States	72758
3	Beverly Hills	Beverly Hills	California	United States	90210
4	Glendale	Glendale	California	United States	91206
5	Oakland	Oakland	California	United States	94607
6	Oceanside	Oceanside	California	United States	92056
7	Orange	Orange	California	United States	92868
8	Riverside	Riverside	California	United States	92506
9	San Diego	San Diego	California	United States	92123
10	San Diego	San Diego	California	United States	92161
11	Temecula	Temecula	California	United States	92591
12	Colorado Springs	Colorado Springs	Colorado	United States	80910
13	Jacksonville	Jacksonville	Florida	United States	32256
14	Lake City	Lake City	Florida	United States	32607
15	Lauderhill	Lauderhill	Florida	United States	33319
16	Tampa	Tampa	Florida	United States	33609
17	Atlanta	Atlanta	Georgia	United States	30341
18	New Bedford	New Bedford	Massachusetts	United States	02740
19	Flowood	Flowood	Mississippi	United States	39232
20	Las Vegas	Las Vegas	Nevada	United States	89102
21	Berlin	Berlin	New Jersey	United States	08009
22	Cedarhurst	Cedarhurst	New York	United States	11516
23	New York	New York	New York	United States	10128
24	Canton	Canton	Ohio	United States	44718
25	Cincinnati	Cincinnati	Ohio	United States	45219
26	Dayton	Dayton	Ohio	United States	45417
27	Oklahoma City	Oklahoma City	Oklahoma	United States	73103
28	Charleston	Charleston	South Carolina	United States	29407
29	Austin	Austin	Texas	United States	78754
30	Dallas	Dallas	Texas	United States	75231
31	Houston	Houston	Texas	United States	77098
32	San Antonio	San Antonio	Texas	United States	78229