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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tonix Pharmaceuticals, Inc.
• Treatments: Cyclobenzaprine

Criteria

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:

• None