BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)

Primary Fibromyalgia Clinical Trial

— BESTFIT  

Official title:

A Phase 2b, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken at Bedtime in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903265
• Other study ID #: TNX-CY-F202
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 12, 2013
• Last updated: November 5, 2015
• Start date: September 2013
• Est. completion date: November 2015

Study information

• Verified date: November 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

TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime has shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial is 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: November 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

• Increase risk of suicide

• Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.

• Unability to wash-out specific medications (ask PI)

• Known hypersensitivity to cyclobenzaprine

• Others: seizure disorders, sleep apnea, CPAP use, BMI>40

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Primary Fibromyalgia

Intervention

Drug:
• TNX-102 SL 2.8mg Tablets
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
• Placebo
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

Locations

Country	Name	City	State
United States	1951 152nd Place NE	Bellevue	Washington
United States	16176 Cortez Boulevard	Brooksville	Florida
United States	3401 North Central Avenue	Chicago	Illinois
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	107 Scripps Drive	Sacramento	California
United States	1002 E. South Temple	Salt Lake City	Utah
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	Average perceived pain	To evaluate the efficacy of TNX-102 (low-dose cyclobenzaprine) sublingual (SL) tablets taken at bedtime over 12 weeks of treatment using an 11-point (0-10) numerical rating scale (NRS) to assess average daily pain over 24 hours.	Weeks 12 mean change of perceived average pain intensity from baseline	No
Secondary	Patient's Global Impression of Change		Weeks 2, 4, 8 and 12 or early termination	No
Secondary	Fibromyalgia Impact Questionnaire		Baseline and weeks 2, 4, 8 and 12	No
Secondary	Patient pain improvement response rate		Weekly	No
Secondary	SF-36 Physical Component score		Baseline and weeks 4, 8 and 12	No
Secondary	Safety of TNX-102 SL Tablets	Every adverse events occurring during the study period will be reported.	Continuously throughout the treatment period (total duration: about 3 months)	Yes