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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01903265
First received: July 12, 2013
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Primary Fibromyalgia
Drug: TNX-102 SL 2.8mg Tablets
Drug: Placebo
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Tonix Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Average perceived pain [ Time Frame: Weeks 12 mean change of perceived average pain intensity from baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient's Global Impression of Change [ Time Frame: Weeks 2, 4, 8 and 12 or early termination ] [ Designated as safety issue: No ]
  • Fibromyalgia Impact Questionnaire [ Time Frame: Baseline and weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Patient pain improvement response rate [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • SF-36 Physical Component score [ Time Frame: Baseline and weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Safety of TNX-102 SL Tablets [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ] [ Designated as safety issue: Yes ]
    Every adverse events occurring during the study period will be reported.


Estimated Enrollment: 200
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TNX-102 SL 2.8 mg Tablets
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.
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.
Other Name: Low dose cyclobenzaprine sublingual tablets
Placebo Comparator: Placebo
1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Drug: Placebo
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
Other Name: Placebo sublingual tablets

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903265

Locations
United States, Colorado
Radiant Research, Inc.
Denver, Colorado, United States, 80239
United States, Florida
16176 Cortez Boulevard
Brooksville, Florida, United States, 34601
100 West Gore Street
Orlando, Florida, United States, 32806
United States, Maryland
71 Thomas Johnson Drive
Frederick, Maryland, United States, 21702
United States, Massachusetts
370 Faunce Corner Road
North Dartmouth, Massachusetts, United States, 02747
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01605
United States, Mississippi
CRC of Jackson, LLC
Jackson, Mississippi, United States, 39202
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45219
1275 Olentangy River Road
Columbus, Ohio, United States, 43212
18660 Bagley Road
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
1001 South Market Street
Mechanicsburg, Pennsylvania, United States, 17055
United States, South Carolina
322 Memorial Drive
Greer, South Carolina, United States, 29650
United States, Washington
601 Broadway
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
Study Director: Mark R. Schmal Premier Research
Study Chair: Daniel J. Clauw, MD Ann Harbor, MI
  More Information

No publications provided

Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01903265     History of Changes
Other Study ID Numbers: TNX-CY-F202
Study First Received: July 12, 2013
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tonix Pharmaceuticals, Inc.:
pain
sleep

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Cyclobenzaprine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 22, 2014