12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients

• Status: Terminated
• Trial end date: 2018-07-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tonix Pharmaceuticals, Inc.
• Collaborator: Premier Research Group plc
• Treatments: Cyclobenzaprine

Criteria

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:

• None.