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A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD (RECOVERY)

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ClinicalTrials.gov Identifier: NCT03841773
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Study Description
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Brief Summary:
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

Condition or disease Intervention/treatment Phase
PTSD Drug: TNX-102 SL Drug: Placebo SL Tablets Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)
Actual Study Start Date : March 7, 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: TNX-102 SL Tablet 2.8 mg
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
 Drug: TNX-102 SL
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
Other Names:
  • Low dose cyclobenzaprine sublingual tablets
  • Tonmya(R)
Placebo Comparator: Placebo SL Tablet
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
 Drug: Placebo SL Tablets
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
Other Names:
  • Placebo sublingual tablets
  • TNX-102 SL Placebo Tablets


Outcome Measures
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Primary Outcome Measures :
  1. The mean change from baseline (Visit 2) in the Total CAPS-5 score evaluated at the landmark visit. [ Time Frame: Week 0, Week 4, Week 8 and Week 12 ]

Secondary Outcome Measures :
  1. Change from baseline in CGI-S score. [ Time Frame: Week 0, Week 4, Week 8 and Week 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening)
  • Index trauma must have occurred within 9 years of Screening Visit
  • Must have occurred when the patient was ≥18 years of age

Exclusion Criteria:

  • Use of antidepressant medication within 2 months of Baseline
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841773


Contacts
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Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com

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Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
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Study Director: Gregory M Sullivan, MD Tonix Pharmaceuticals
More Information
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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03841773     History of Changes
Other Study ID Numbers: TNX-CY-P302
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tonix Pharmaceuticals, Inc.:
PTSD

Additional relevant MeSH terms:
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Cyclobenzaprine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
 Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
Central Nervous System Depressants