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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2020-07-22 |
| Est. Completion | 2021-11-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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