Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 66
Updated:11/2/2017
Start Date:April 2015
End Date:August 2016

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A 12-Week, Open-Label, Multicenter, Extension Study To TNX-CY-P201 To Evaluate The Safety And Efficacy Of TNX-102 SL Taken Daily At Bedtime In Patients With Military-Related PTSD And Related Conditions

This is a 12-week, multicenter, open-label extension study to evaluate the safety and
efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD
or related condition. Patients recruited into this trial are those who have successfully
completed the double-blind study, TNX-CY-P201 (AtEase Study). Patients will not be made aware
of the therapy they received during the double-blind study.

The study will consist of 4 clinic visits, including Screening/Baseline Visit 1 (Day 0, which
is anticipated to be the same date as the final visit in the lead-in P201 study) and visits
after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for
refraining from the use of certain concomitant medications and trauma-focused psychotherapies
will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or
they may utilize other medications as needed to help them sleep, per the judgment of the
investigator.

Eligible patients who provide written informed consent will take one TNX-102 SL tablet daily
at bedtime sublingually (under the tongue) for 12 weeks. All patients will be assigned to
receive tthe same dosage of TNX-102 SL, regardless of their treatment assignment in the
lead-in study. No patients, investigators, or study staff will know the assigned study
treatment from the lead-in study, P201, at the time of entry into the extension study.
Patient data collected at the Week 12 visit (Visit 9) in the lead-in P201 study will be used
as one of the baseline values for this study.

Inclusion Criteria:

- Completed the lead-in study and is judged as reasonably compliant, with at least 60%
compliance

- Signed informed consent

- Met all prior inclusion and exclusion requirements for lead-in study

- No new or worsening medical conditions since starting the lead-in study that could
pose a safety risk or interfere with participation in the study

- Willing to refrain from use of specific medication (ask PI)

- Female patients of childbearing potential continue to practice medically acceptable
methods of birth control

Exclusion Criteria:
We found this trial at
22
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
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Bellevue, Washington 98007
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Cedarhurst, New York 11516
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Chicago, Illinois 60640
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Chicago, IL
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Cleveland, OH
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Imperial, California 92251
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Lake City, Florida 32025
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Las Vegas, Nevada 89102
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Leesburg, Florida 34748
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National City, California 91950
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New Bedford, Massachusetts 02740
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Oceanside, California 92056
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Orlando, Florida 32806
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Phoenix, Arizona 85032
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Riverside, California 92506
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San Diego, California 92103
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Torrance, California 90502
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Tuscaloosa, Alabama 35404
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