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

Stopped early · Phase 3

Conditions studied: PTSD

In brief

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.

Key facts

Study ID

NCT03110575

Run by

Tonix Pharmaceuticals, Inc.

People needed

190

Starts

2017-06-20

Expected to finish

2018-07-27

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• None.

Where it is running

• Phoenix — Phoenix, Arizona, United States
• Rogers — Rogers, Arkansas, United States
• Beverly Hills — Beverly Hills, California, United States
• Glendale — Glendale, California, United States
• Oakland — Oakland, California, United States
• Oceanside — Oceanside, California, United States
• Orange — Orange, California, United States
• Riverside — Riverside, California, United States
• San Diego — San Diego, California, United States
• San Diego — San Diego, California, United States
• Temecula — Temecula, California, United States
• Colorado Springs — Colorado Springs, Colorado, United States
• Jacksonville — Jacksonville, Florida, United States
• Lake City — Lake City, Florida, United States
• Lauderhill — Lauderhill, Florida, United States
• Tampa — Tampa, Florida, United States
• Atlanta — Atlanta, Georgia, United States
• New Bedford — New Bedford, Massachusetts, United States
• Flowood — Flowood, Mississippi, United States
• Las Vegas — Las Vegas, Nevada, United States
• Berlin — Berlin, New Jersey, United States
• Cedarhurst — Cedarhurst, New York, United States
• New York — New York, New York, United States
• Canton — Canton, Ohio, United States
• Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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