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

NCT01903265 | Completed Phase 2 Results

• 1 other identifier: TNX-CY-F202
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Primary Fibromyalgia

Keywords

pain; sleep

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12

  Daily pain scores were assessed using a 24-hour recall response provided by each patient via an interactive voice response system (IVRS) daily telephone diary. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Jump to control was used to replace missing data in each treatment arm.

  Baseline, Week 12

Secondary Outcomes (4)

• 30% Responder Analysis of IVRS NRS Pain Assessments at Week 12

  Baseline, Week 12

• Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance

  Baseline, Week 12

• Patient Global Impression of Change (PGIC) Responder Status ("Very Much Improved" or "Much Improved" vs All Other Categories) at Week 12

  Week 12

• Change From Baseline to Week 12 in FIQ-R Total Score

  Baseline, Week 12

Study Arms (2)

TNX-102 SL 2.8 mg

EXPERIMENTAL

Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks.

Drug: TNX-102 SL 2.8mg

Placebo

PLACEBO COMPARATOR

Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks.

Drug: Placebo

Interventions

TNX-102 SL 2.8mg DRUG

Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

Also known as: Low dose cyclobenzaprine sublingual tablets

TNX-102 SL 2.8 mg

Placebo DRUG

Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

Also known as: Placebo sublingual tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead

Study Sites (17)

107 Scripps Drive

Sacramento, California, 95825, United States

Location

Radiant Research, Inc.

Denver, Colorado, 80239, United States

Location

16176 Cortez Boulevard

Brooksville, Florida, 34601, United States

Location

100 West Gore Street

Orlando, Florida, 32806, United States

Location

3401 North Central Avenue

Chicago, Illinois, 60634, United States

Location

71 Thomas Johnson Drive

Frederick, Maryland, 21702, United States

Location

370 Faunce Corner Road

North Dartmouth, Massachusetts, 02747, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

CRC of Jackson, LLC

Jackson, Mississippi, 39202, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45219, United States

Location

1275 Olentangy River Road

Columbus, Ohio, 43212, United States

Location

18660 Bagley Road

Middleburg Heights, Ohio, 44130, United States

Location

1001 South Market Street

Mechanicsburg, Pennsylvania, 17055, United States

Location

322 Memorial Drive

Greer, South Carolina, 29650, United States

Location

1002 E. South Temple

Salt Lake City, Utah, 84102, United States

Location

1951 152nd Place NE

Bellevue, Washington, 98007, United States

Location

601 Broadway

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gregory M. Sullivan, MD, Chief Medical Officer
• Organization: Tonix Pharmaceuticals

Gregory.Sullivan@TonixPharma.com

212 980 9155

Study Officials

• Mark R. Schmal

  Premier Research

  STUDY DIRECTOR

• Daniel J. Clauw, MD

  Ann Arbor, MI

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 19, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 23, 2016
• Results First Posted: December 23, 2016

Record last verified: 2016-10

Locations

US (17)