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NCT04508621 · ClinicalTrials.gov registry record · Phase 3

A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

A Phase 3 study, sponsored by Tonix Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
514
Enrollment target

NCT04508621 is a Phase 3 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 514 participants.

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The verdict

NCT04508621, a Phase 3 study, has completed, sponsored by Tonix Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
514 participants
Enrollment target

Study Summary

This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.

Interventions

  • DRUG TNX-102 SL
  • DRUG Placebo SL Tablet

Trial Details

FieldValue
Enrollment Target 514 participants
Start Date 2020-07-22
Est. Completion 2021-11-01
Phase Phase 3

Sponsor

Tonix Pharmaceuticals

23 total trials

What the Registry Record Tells You About NCT04508621

The ClinicalTrials.gov registry entry for NCT04508621 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 514 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tonix Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which TNX-102 SL is the first listed.

NCT04508621 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04508621 about?

NCT04508621 is a clinical study titled "A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia". This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.

What is the current status of trial NCT04508621?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2020-07-22. Estimated completion is 2021-11-01.

What interventions are being tested in trial NCT04508621?

The interventions under investigation include: TNX-102 SL (DRUG), Placebo SL Tablet (DRUG).

Who is sponsoring clinical trial NCT04508621?

This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.