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NCT02436096 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia
A Phase 3 study, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 519
- Enrollment target
NCT02436096 is a Phase 3 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 519 participants.
The verdict
NCT02436096, a Phase 3 study, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 519 participants
- Enrollment target
Study Summary
The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology. The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.
Interventions
- DRUG Placebo SL Tablet
- DRUG TNX-102 SL Tablet, 2.8mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 519 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02436096
The ClinicalTrials.gov registry entry for NCT02436096 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 519 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 Placebo SL Tablet is the first listed.
NCT02436096 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02436096 about?
NCT02436096 is a clinical study titled "A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia". The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM ...
What is the current status of trial NCT02436096?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 519 participants. The study started on 2015-04. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02436096?
The interventions under investigation include: Placebo SL Tablet (DRUG), TNX-102 SL Tablet, 2.8mg (DRUG).
Who is sponsoring clinical trial NCT02436096?
This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
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