A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients

Study Overview
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Brief Summary
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This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302. Anticipated start for TNX-CY-F302 is for March 2016. Patients will not be made aware of the therapy they received during the double-blind study.

Detailed Description
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The study consist of 4 study visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as Visit 6 in F301 or F302) and visits after 1, 2 and 3 months of treatment (Visits 2-4). Primary: The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 3 months in patients with FM who have completed the double-blinded lead-in study Secondary: The secondary objective is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of FM

Official Title
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A 3-Month, Multicenter, Open-Label Extension to Evaluate Safety and Efficacy of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia

Conditions
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Primary Fibromyalgia

Intervention / Treatment
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* Drug: TNX-102 SL Tablet 2.8 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient met all prior inclusion and exclusion requirements for study F301 or F302 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 F301 or F302 defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on overall drug accountability reconciliation at the end of the F301 or F302 lead-in study) and no major protocol deviations. The patient has provided written informed consent to participate in this extension protocol. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNX-102 SL Tablet 2.8 mg<br>1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 3 months | Drug: TNX-102 SL Tablet 2.8 mg<br>* TNX-102 SL 2.8 mg tablet taken daily at bedtime<br>* Other names: cyclobenzaprine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be assessed by AEs, clinical laboratory tests, vital signs, physical examination, oral cavity examinations, Columbia C-SSRS scale, and depression status using the BDI. | Safety will be assessed by the monitoring and recording of AEs, clinical laboratory tests, vital signs, physical examination findings including oral cavity examinations, the monitoring of suicidality using the Columbia C-SSRS scale, and depression status using the BDI. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: 24-hour and 7-day recall assessments of the pain of FM using an in-clinic 11-point (0-11) NRS administered at Months 1, 2 and 3 | 24-hour and 7-day recall assessments of the pain of FM using an in-clinic 11-point (0-11) NRS administered at Months 1, 2 and 3 | 1, 2 and 3 months | 
| Efficacy: Patient's Global Impression of Change (PGIC) at Months 1, 2 and 3 | Patient's Global Impression of Change (PGIC) at Months 1, 2 and 3 | 1, 2 and 3 months | 
| Efficacy: Fibromyalgia Impact Questionnaire - Revised (FIQR) total, individual domain and item scores at Months 1, 2 and 3 | Fibromyalgia Impact Questionnaire - Revised (FIQR) total, individual domain and item scores at Months 1, 2 and 3 | 1, 2 and 3 months | 
| Efficacy: Patient Reported Outcomes Measurement Information System (PROMIS) scale for fatigue at Months 1, 2 and 3 | Patient Reported Outcomes Measurement Information System (PROMIS) scale for fatigue at Months 1, 2 and 3 | 1, 2 and 3 months | 
| Efficacy: Patient Reported Outcomes Measurement Information System (PROMIS) scale for sleep disturbance at Months 1, 2 and 3 | Patient Reported Outcomes Measurement Information System (PROMIS) scale for sleep disturbance at Months 1, 2 and 3 | 1, 2 and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TNX-102 SL, bedtime, sublingual, 3-month, long term safety, long term efficacy, Fibromyalgia