Phase 3
Completed N=205
BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
Primary Fibromyalgia
Source: ClinicalTrials.gov NCT01903265 ↗
Enrolled (actual)
205
Serious AEs
0.5%
Results posted
Dec 2016
Primary outcomePrimary: Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12 — -1.39; -0.95 units on a scale
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12 |
-1.39; -0.95 | — |
| SECONDARY 30% Responder Analysis of IVRS NRS Pain Assessments at Week 12 |
34; 20.6 | — |
| SECONDARY Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance |
-8.96; -5.13 | — |
| SECONDARY Patient Global Impression of Change (PGIC) Responder Status ("Very Much Improved" or "Much Improved" vs All Other Categories) at Week 12 |
30.1; 16.7 | — |
| SECONDARY Change From Baseline to Week 12 in FIQ-R Total Score |
-15.59; -8.54 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary Fibromyalgia (ACR criteria)
- Male or female 18-65 years old
- For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent therapy
- Willing and able to withdraw specific therapies (ask PI)
- Medically acceptable form of contraception (female only)
- Signed informed consent
Exclusion Criteria
- Arthritis, lupus and other systemic auto-immune diseases
- Regional or persistent pain that could interfere with assessment of fibromyalgia pain
- Bipolar and psychotic disorders
- Increased risk of suicide
- Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
- Inability to wash-off specific medications (ask PI)
- Known hypersensitivity to cyclobenzaprine
- Others: seizure disorders, sleep apnea, continuous positive airway pressure (CPAP) use, BMI>40
Data sourced from ClinicalTrials.gov (NCT01903265). 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.