Clinical trial NCT01903265: BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Primary Fibromyalgia
Keywords: pain
sleep
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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
* 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

Primary outcomes:
measure: Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: 30% Responder Analysis of IVRS NRS Pain Assessments at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance
timeFrame: Baseline, Week 12
measure: Patient Global Impression of Change (PGIC) Responder Status ("Very Much Improved" or "Much Improved" vs All Other Categories) at Week 12
timeFrame: Week 12
measure: Change From Baseline to Week 12 in FIQ-R Total Score
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: 107 Scripps Drive
state: California
city: Denver
country: United States
facility: Radiant Research, Inc.
state: Colorado
city: Brooksville
country: United States
facility: 16176 Cortez Boulevard
state: Florida
city: Orlando
country: United States
facility: 100 West Gore Street
state: Florida
city: Chicago
country: United States
facility: 3401 North Central Avenue
state: Illinois
city: Frederick
country: United States
facility: 71 Thomas Johnson Drive
state: Maryland
city: North Dartmouth
country: United States
facility: 370 Faunce Corner Road
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Jackson
country: United States
facility: CRC of Jackson, LLC
state: Mississippi
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Columbus
country: United States
facility: 1275 Olentangy River Road
state: Ohio
city: Middleburg Heights
country: United States
facility: 18660 Bagley Road
state: Ohio
city: Mechanicsburg
country: United States
facility: 1001 South Market Street
state: Pennsylvania
city: Greer
country: United States
facility: 322 Memorial Drive
state: South Carolina
city: Salt Lake City
country: United States
facility: 1002 E. South Temple
state: Utah
city: Bellevue
country: United States
facility: 1951 152nd Place NE
state: Washington
city: Seattle
country: United States
facility: 601 Broadway
state: Washington
Study officials:
affiliation: Premier Research Group plc
name: Mark R. Schmal
role: STUDY_DIRECTOR
affiliation: Ann Arbor, MI
name: Daniel J. Clauw, MD
role: STUDY_CHAIR
References: