12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients (BESTFIT-OLE)

A 12-Month, Multicenter, Open-Label Extension Study (F202) to Evaluate the Long-term Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia

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.

Study Overview

• Status: Completed
• Conditions: Primary Fibromyalgia
• Intervention / Treatment: Drug: TNX-102 SL

Detailed Description

The study consisted of 7 clinic visits, including Screening/Baseline Visit 1 (Day 0 which was typically the same date as Visit 6 of the double-blind lead-in study), visits after 1, 3, 6, 9, and 12 months of treatment (Visits 2-6), and a Follow-up Visit (Visit 7) scheduled within one month after stopping study drug treatment.

Primary:

The primary objective of the study was to evaluate the long-term safety of TNX-102 SL tablets taken daily at bedtime over 12 months in patients with fibromyalgia who have completed Study TNX-CY-F202 (NCT01903265)

Secondary:

The secondary objective was to evaluate the long-term efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of fibromyalgia

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80239
      • Denver
  • Florida
    • Brooksville, Florida, United States, 34601
      • 16176 Cortez Boulevard
    • Orlando, Florida, United States, 32806
      • 100 West Gore Street
  • Maryland
    • Frederick, Maryland, United States, 21702
      • 71 Thomas Johnson Drive
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • 370 Faunce Corner Road
    • Worcester, Massachusetts, United States, 01605
      • Worcester
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Jackson
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Cincinnati
    • Columbus, Ohio, United States, 43212
      • 1275 Olentangy River Road
    • Middleburg Heights, Ohio, United States, 44130
      • 18660 Bagley Road
  • Pennsylvania
    • Mechanicsburg, Pennsylvania, United States, 17055
      • 1001 South Market Street
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • 322 Memorial Drive
  • Washington
    • Seattle, Washington, United States, 98122
      • 601 Broadway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. 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.
3. The patient has provided written informed consent to participate in this extension protocol.

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TNX-102 SL; 1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months	Drug: TNX-102 SL; TNX-102 SL 2.8 mg taken daily at bedtime.; Other Names: cyclobenzaprine HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.	NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall	The NRS for average pain was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 24-hour recall basis.	Months 1, 3, 6, 9 and 12.
Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall	The NRS for average pain over the past 7 days was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 7-day recall basis.	Month 1, 3, 6, 9, 12
Responder Analysis of Patient's Global Impression of Change (PGIC)	PGIC is a fibromyalgia-specific validated instrument to gauge the patient's assessment of change in condition.The scores are categorized as provided below. A responder was defined by a score of 1 (very much improved), or 2 (much improved).; = Very much improved; = Much improved; = Minimally improved; = No change; = Minimally worse; = Much worse; = Very much worse	Months 1, 3, 6, 9, 12

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.
• Investigators: Study Director: Gregory Sullivan, Tonix Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (Estimate): December 19, 2013

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Fibromyalgia; sublingual; long term safety; TNX-102 SL; bedtime; long term efficacy; 12-month
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antidepressive Agents, Tricyclic; Neuromuscular Agents; Muscle Relaxants, Central; Cyclobenzaprine
• Other Study ID Numbers: TNX-CY-F203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED