Clinical trial NCT02589275: A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients
Official title: A 3-Month, Multicenter, Open-Label Extension to Evaluate Safety and Efficacy of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Fibromyalgia
Keywords: TNX-102 SL
bedtime
sublingual
3-month
long term safety
long term efficacy
Fibromyalgia
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-28
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302.

Patients will not be made aware of the therapy they received during the double-blind study.

Detailed description: The study consist of 4 study visits, including Screening/Baseline Visit 1 (Day 1, which is anticipated to be the same date as Visit 6 in F301 or F302) and visits after 1, 2 and 3 months of treatment (Visits 2-4).

Primary:

The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 3 months in patients with FM who have completed the double-blinded lead-in study

Secondary:

The secondary objective is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of FM

Eligibility criteria: Inclusion Criteria:

* The patient met all prior inclusion and exclusion requirements for study F301 or F302 originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the extension study.
* The patient completed expected dosing in F301 or F302 defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on overall drug accountability reconciliation at the end of the F301 or F302 lead-in study) and no major protocol deviations.
* The patient has provided written informed consent to participate in this extension protocol.

Exclusion Criteria:

* None

Primary outcomes:
measure: Newly Emergent Adverse Events
timeFrame: Up to 3 months from first dose
Secondary outcomes:
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: 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: 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: