12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
| Status: | Terminated |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/5/2018 |
| Start Date: | June 20, 2017 |
| End Date: | July 27, 2018 |
A 12-Week Open-Label Extension Study to Evaluate TNX-102 SL Taken Daily at Bedtime in Patients With PTSD
This is an open-label, extension trial designed to evaluate safety over 12 additional weeks
of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited
into this trial are those who have successfully completed the double-blind lead-in study.
of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited
into this trial are those who have successfully completed the double-blind lead-in study.
The study will consist of 5 study visits, including Screening/Baseline Visit 1 (Day 0, which
is anticipated to be the same visit as the last visit on double-blind treatment), a phone
visit after 2 weeks of treatment, and in-clinic visits after 4, 8, and 12 weeks of treatment.
The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken
daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a
double-blinded lead-in study.
The secondary objective of the study is to evaluate the efficacy of TNX-102 SL tablets taken
daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a
double-blinded lead-in study.
is anticipated to be the same visit as the last visit on double-blind treatment), a phone
visit after 2 weeks of treatment, and in-clinic visits after 4, 8, and 12 weeks of treatment.
The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken
daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a
double-blinded lead-in study.
The secondary objective of the study is to evaluate the efficacy of TNX-102 SL tablets taken
daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a
double-blinded lead-in study.
Inclusion Criteria:
- The patient has completed the final treatment study visit of the lead-in study and
remained compliant with the lead-in protocol and study treatment.
- The patient has provided written informed consent to participate in this extension
protocol.
- 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:
We found this trial at
31
sites
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