A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD

Completed · Phase 3

Conditions studied: PTSD

In brief

Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label extension study (TNX-CY-P303).

Key facts

Study ID

NCT03508700

Run by

Tonix Pharmaceuticals, Inc.

People needed

93

Starts

2018-04-19

Expected to finish

2019-09-30

Last updated by the study team

2025-02-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient has completed a double-blind lead-in HONOR study and a 12-week open-label extension study P303 and is judged by the investigator as reasonably compliant, with at least 60% compliance with study medication usage (based on drug accountability).
• The patient has provided written informed consent to participate in this extension study.
• The patient met all prior inclusion and exclusion requirements for the double-blind lead-in HONOR study, or the site received medical monitor approval for the patient to remain in the lead-in study after the retrospective discovery of an entry violation that did not pose any threat to the patient's safety or well-being.
• During the course of the lead-in HONOR study or 12-week open-label extension P303 study, the patient has had no intervening medical conditions including pregnancy, clinically significant increase in suicidal ideation (plan or intent) or significant worsening of depression, newly arising clinically significant abnormal laboratory tests, or any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the patient's ability to participate in the study or potentially compromise the patient's well-being during the study.
• The patient does not require treatment with a potent (strong) cytochrome P450 subtype 3A4 (CYP3A4) inhibitor, or St. John's wort.
• The patient is willing to refrain from use of all other formulations of cyclobenzaprine for the duration of the study.
• The patient is willing to refrain from use of monoamine oxidase inhibitors for the duration of the study.
• 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.

You may not qualify if…

• There are no exclusion criteria for this study.

Where it is running

• Little Rock — Little Rock, Arkansas, United States
• Beverly Hills — Beverly Hills, California, United States
• Oceanside — Oceanside, California, United States
• Orange — Orange, California, United States
• Temecula — Temecula, California, United States
• Colorado Springs — Colorado Springs, Colorado, United States
• Norwich — Norwich, Connecticut, United States
• Tampa — Tampa, Florida, United States
• Atlanta — Atlanta, Georgia, United States
• New Bedford — New Bedford, Massachusetts, United States
• Las Vegas — Las Vegas, Nevada, United States
• Cedarhurst — Cedarhurst, New York, United States
• New York — New York, New York, United States
• Canton — Canton, Ohio, United States
• Cincinnati — Cincinnati, Ohio, United States
• Oklahoma City — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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