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NCT02015234 · ClinicalTrials.gov registry record · Phase 3
12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
A Phase 3 study of Primary Fibromyalgia, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
- 13
- Study locations
NCT02015234 is a Phase 3 study of Primary Fibromyalgia that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 158 participants. The trial reports 13 study locations across 9 states.
The verdict
NCT02015234, a Phase 3 study of Primary Fibromyalgia, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 158 participants
- Enrollment target
- 13
- Study locations
Study Summary
This was an open-label, extension trial designed to evaluate the long-term safety over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia. Patients recruited into this trial were those who had successfully completed the double-blind study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they received during the double-blind study.
Conditions Studied
Interventions
- DRUG TNX-102 SL
Study Locations (13)
Ohio
- Cincinnati - Cincinnati
- 1275 Olentangy River Road - Columbus
- 18660 Bagley Road - Middleburg Heights
Florida
- 16176 Cortez Boulevard - Brooksville
- 100 West Gore Street - Orlando
Massachusetts
- 370 Faunce Corner Road - North Dartmouth
- Worcester - Worcester
Colorado
- Denver - Denver
Maryland
- 71 Thomas Johnson Drive - Frederick
Mississippi
- Jackson - Jackson
Pennsylvania
- 1001 South Market Street - Mechanicsburg
South Carolina
- 322 Memorial Drive - Greer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02015234
The ClinicalTrials.gov registry entry for NCT02015234 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 158 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 1 condition, with Primary Fibromyalgia appearing as the primary indexed condition, and to 1 intervention - of which TNX-102 SL is the first listed.
NCT02015234 reports 13 study locations spanning 9 distinct geographic areas - top geographies include Ohio, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02015234 about?
NCT02015234 is a clinical study titled "12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients". This was an open-label, extension trial designed to evaluate the long-term safety over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia. Patients recruited into this trial were those who had successfully completed the double-blind study, TNX-CY-F202 (F202) (NC...
What is the current status of trial NCT02015234?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2013-12. Estimated completion is 2015-08.
What conditions does trial NCT02015234 study?
This clinical trial studies the following conditions: Primary Fibromyalgia.
What interventions are being tested in trial NCT02015234?
The interventions under investigation include: TNX-102 SL (DRUG).
Who is sponsoring clinical trial NCT02015234?
This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02015234 being conducted?
This trial has 13 study locations across Colorado, Florida, Maryland, Massachusetts, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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