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

Primary Fibromyalgia Clinical Trial

— BESTFIT-OLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015234
• Other study ID #: TNX-CY-F203
• Status: Completed
• Phase: Phase 3
• First received: December 9, 2013
• Last updated: October 23, 2015
• Start date: December 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3, 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 FM. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-F202 (F202). Patients will not be made aware of the therapy they received during the double-blind study.

Description:

The study will consist of 7 clinic visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as Visit 6 in F202), 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 is to evaluate the long-term safety of TNX-102 SL tablets taken daily at bedtime over 12 months in patients with FM who have completed Study TNX-CY-F202

Secondary:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. The patient met all prior inclusion and exclusion requirements for Study F202 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 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) and no major protocol violations.

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

Exclusion Criteria:

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Primary Fibromyalgia

Intervention

Drug:
• TNX-102 SL
TNX-102 2.8 mg SL taken daily at bedtime.

Locations

Country	Name	City	State
United States	16176 Cortez Boulevard	Brooksville	Florida
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	1275 Olentangy River Road	Columbus	Ohio
United States	Radiant Research, Inc.	Denver	Colorado
United States	71 Thomas Johnson Drive	Frederick	Maryland
United States	322 Memorial Drive	Greer	South Carolina
United States	CRC of Jackson, LLC	Jackson	Mississippi
United States	1001 South Market Street	Mechanicsburg	Pennsylvania
United States	18660 Bagley Road	Middleburg Heights	Ohio
United States	370 Faunce Corner Road	North Dartmouth	Massachusetts
United States	100 West Gore Street	Orlando	Florida
United States	601 Broadway	Seattle	Washington
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class. Adverse events will also be summarized by severity and relationship to study drug. Serious AEs and AEs leading to discontinuation of study drug will also be summarized. Actual values and changes from extension Baseline for clinical laboratory test results and vital sign measurements will be summarized at endpoint using descriptive statistics (n, mean, SD, median, minimum, and maximum).	every 3 month	No
Secondary	Efficacy	24 hour recall pain. Change from both baselines in NRS assessments of 24 hour recall pain at months 1, 3, 6, 9 and 12.; Weekly recall pain. Change from both baselines in NRS assessments of 7 day recall pain at months 1, 3, 6, 9 and 12.; Fibromyalgia Impact Questionnaire (FIQ). Change from both baselines in FIQ total score at months 1, 3, 6, 9 and 12.; Patient Global Impression of Change (PGIC). A responder analysis of PGIC score at Months 1, 3, 6, 9, and 12 where a responder is defined as a score of 1 or 2 on the PGIC; Change from both baselines in SF-36 scores at Months 1, 3, 6, 9, and 12; Change from both baselines in the Patient Reported Outcomes Measurement System (PROMIS) for sleep disturbance and fatigue at Months 1, 3, 6, 9 and 12	24 hour recall pain at months 1, 3, 6, 9 and 12	No