Phase 3
Completed N=158
12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
Primary Fibromyalgia
Source: ClinicalTrials.gov NCT02015234 ↗
Enrolled (actual)
158
Serious AEs
5.1%
Results posted
Jul 2017
Primary outcomePrimary: Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia. — 60; 54; 18; 9 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia. |
60; 54; 18; 9; 3; 5 | — |
| SECONDARY Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall |
5.6; 5.0; -0.5; -0.2; -0.5; -0.3 | — |
| SECONDARY Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall |
5.7; 4.8; -0.8; 0.1; -0.6; 0.1 | — |
| SECONDARY Responder Analysis of Patient's Global Impression of Change (PGIC) |
16; 25; 63; 54; 23; 29 | — |
Eligibility Criteria
Inclusion Criteria
- The patient met all prior inclusion and exclusion requirements for Study F202 (NCT01903265) originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the extension study.
- The patient completed expected dosing in F202 (NCT01903265) defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on responses from daily IVRS calls recorded during the F202 study (NCT01903265)) and no major protocol violations.
- The patient has provided written informed consent to participate in this extension protocol.
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT02015234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.