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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
93
cyclobenzaprine HCl sublingual tablets
Little Rock
Little Rock, Arkansas, United States
Beverly Hills
Beverly Hills, California, United States
Oceanside
Oceanside, California, United States
Incidence of Newly Emergent Adverse Events
Evaluate the incidence of newly emergent adverse events over an additional 40 weeks of treatment with TNX-102 SL 5.6 mg in patients with PTSD who have participated in a double-blinded lead-in study. 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.
Time frame: 40 weeks
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Colorado Springs, Colorado, United States
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Atlanta, Georgia, United States
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New Bedford, Massachusetts, United States
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