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COMPLETED Phase 3

A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD

NCT03508700 · View on ClinicalTrials.gov ↗

Study Summary

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).

Conditions Studied

Interventions

  • DRUG TNX-102 SL 5.6 mg

Study Locations (16)

California

  • Beverly Hills — Beverly Hills
  • Oceanside — Oceanside
  • Orange — Orange
  • Temecula — Temecula

New York

  • Cedarhurst — Cedarhurst
  • New York — New York

Ohio

  • Canton — Canton
  • Cincinnati — Cincinnati

Arkansas

  • Little Rock — Little Rock

Colorado

  • Colorado Springs — Colorado Springs

Connecticut

  • Norwich — Norwich

Florida

  • Tampa — Tampa

Georgia

  • Atlanta — Atlanta

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2018-04-19
Est. Completion 2019-09-30
Phase Phase 3

Sponsor

Tonix Pharmaceuticals

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03508700

The ClinicalTrials.gov registry entry for NCT03508700 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tonix Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 1 intervention — of which TNX-102 SL 5.6 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03508700 reports 16 study locations spanning 11 distinct geographic areas — top geographies include California, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03508700 about?

NCT03508700 is a clinical study titled "A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD". 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).

What is the current status of trial NCT03508700?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 93 participants. The study started on 2018-04-19. Estimated completion is 2019-09-30.

What conditions does trial NCT03508700 study?

This clinical trial studies the following conditions: PTSD. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03508700?

The interventions under investigation include: TNX-102 SL 5.6 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03508700?

This trial is sponsored by Tonix Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03508700 being conducted?

This trial has 16 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial