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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: Completed Phase 3 study of Primary Fibromyalgia, sponsored by Tonix Pharmaceuticals.
NCT02015234 is a Phase 3 study of Primary Fibromyalgia that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 158 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).
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 |
What the finished NCT02015234 record still lists
NCT02015234 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
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 lists 13 locations in 9 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02015234's enrollment target sits among peer trials
158 1502nd of 2000 higher than 496 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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