Clinical trial NCT02436096: A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia
Official title: A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Keywords: Pain
Sleep
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 519
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
* Male or female 18-75 years old
* For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressant 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-out specific medications (ask PI)
* Known hypersensitivity to cyclobenzaprine
* Others: seizure disorders, severe/untreated sleep apnea, BMI\>40

Primary outcomes:
measure: Proportion of Patients With ≥30% Pain Improvement
timeFrame: Day 1, Week 12
Secondary outcomes:
measure: Patient's Global Impression of Change (PGIC)
timeFrame: Week 12
measure: Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score
timeFrame: Day 1, Week 12
measure: Change From Baseline to Week 12 in the FIQR Function Domain Score
timeFrame: Day 1, Week 12
measure: Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance
timeFrame: Day 1, Week 12
measure: Weekly Average of Daily Sleep Quality Diary
timeFrame: Baseline (Day -7 to Day -1), Week 12
measure: Patient Reported Outcomes Measurement System (PROMIS) Fatigue
timeFrame: Day 1, Week 12
measure: Weekly Average of Daily Pain Diary
timeFrame: Baseline (Day -7 to Day -1), Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Brandon
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Lakeland
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Smyrna
country: United States
state: Georgia
city: Evansville
country: United States
state: Indiana
city: North Dartmouth
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Williamsville
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Greer
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Kenosha
country: United States
state: Wisconsin
Study officials:
References: