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

July 12, 2013
May 15, 2014
September 2013
December 2014   (final data collection date for primary outcome measure)
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.
Patient-Perceived Pain [ Time Frame: Weeks 12 or early termination mean change of perceived average pain intensity from baseline ] [ Designated as safety issue: No ]
The weekly mean change from baseline of the daily patient-perceived average pain intensity will be assesed from the records of the 24-hour recall responses of the patient via a daily telephone diary, using an 11-point numeric assessment of their pain (0=no pain to 10=worst possible pain). Patients will be asked to complete this assessment on a daily basis during the pre-treatment run-in period and throughout the double-blind treatment period
Complete list of historical versions of study NCT01903265 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Fibromyalgia
  • 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
  • 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
  • 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.
    Intervention: Drug: TNX-102 SL 2.8mg Tablets
  • Placebo Comparator: Placebo
    1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01903265
TNX-CY-F202
No
Tonix Pharmaceuticals, Inc.
Tonix Pharmaceuticals, Inc.
Not Provided
Study Director: Mark R. Schmal Premier Research
Study Chair: Daniel J. Clauw, MD Ann Harbor, MI
Tonix Pharmaceuticals, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP