Clinical trial NCT02829814: Repeat of: 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: TERMINATED
Phase: PHASE3
Conditions: Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Musculoskeletal Diseases
Keywords: Pain
Sleep
Fibromyalgia
FM
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-12
Enrollment: 51
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 present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.

The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
* Male or female 18-75 years old
* Patients currently receiving pharmacologic treatment for depression should have been clinically stable for at least 3 months prior to randomization, and on stable doses of antidepressants during this 3 month time frame.
* Willing and able to withdraw specific therapies (ask PI)
* If female, medically acceptable form of contraception or not of child bearing potential.
* Provide written informed consent to participate.
* Willing and able to comply with all protocol specified requirement.

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\>45

Primary outcomes:
measure: Weekly Mean Pain Score
timeFrame: Day 1, Week 12
Secondary outcomes:
measure: Patient's Global Impression of Change (PGIC)
timeFrame: Week 12
measure: Fibromyalgia Impact Questionnaire (FIQR) Revised, Symptoms Domain
timeFrame: Day 1, Week 12
measure: Fibromyalgia Impact Questionnaire (FIQR) Revised, Functional Domain Score
timeFrame: Day 1, Week 12
measure: Daily Diary Sleep
timeFrame: Week 12
measure: Patient Reported Outcomes Measurement System (PROMIS), Sleep Disturbance
timeFrame: Day 1, Week 12
measure: Patient Reported Outcomes Measurement System (PROMIS), Fatigue
timeFrame: Week 12
measure: Daily Diary Pain
timeFrame: Week -1 (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: Oceanside
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: 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: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Jackson
country: United States
state: Mississippi
city: Las Vegas
country: United States
state: Nevada
city: Cedarhurst
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Mount Pleasant
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
city: Kenosha
country: United States
state: Wisconsin
Study officials:
References: