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



Status:Enrolling by invitation
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 75
Updated:6/9/2018
Start Date:April 19, 2018
End Date:September 2019

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

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).

This is an open-label, extension trial designed to evaluate safety over 40 additional weeks
of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD.

The study will consist of 5 in-clinic study visits, including Baseline Visit 1 (Day 0, which
is anticipated to be the same visit as the last visit of the 12-week open-label extension
study TNX-CY-P303), followed by in-clinic visits after 7, 16, 28 and 40 weeks of open-label
treatment.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- There are no exclusion criteria for this study.
We found this trial at
16
sites
Cincinnati, Ohio 45219
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Atlanta, GA
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Beverly hills, California 90210
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Beverly hills, CA
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Canton, Ohio 44718
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Canton, OH
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Cedarhurst, New York 11516
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Cedarhurst, NY
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Colorado Springs, Colorado 80910
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Colorado Springs, CO
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Las Vegas, Nevada 89119
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Las Vegas, NV
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Little Rock, Arkansas 72211
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Little Rock, AR
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New Bedford, Massachusetts 02740
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New Bedford, MA
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New York, New York 10001
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New York, NY
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Norwich, Connecticut 06360
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Norwich, CT
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Oceanside, California 92056
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Oceanside, CA
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Oklahoma City, Oklahoma 73103
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Oklahoma City, OK
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Orange, California
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Orange, CA
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Tampa, Florida 33603
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Tampa, FL
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Temecula, California 92591
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Temecula, CA
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