12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients



Status:Completed
Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:December 2013
End Date:August 2015

Use our guide to learn which trials are right for you!

A 12-Month, Multicenter, Open-Label Extension Study (F202) to Evaluate the Long-term Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia

This is a Phase 3, open-label, extension trial designed to evaluate the long-term safety
over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of FM.
Patients recruited into this trial are those who have successfully completed the
double-blind study, TNX-CY-F202 (F202). Patients will not be made aware of the therapy they
received during the double-blind study.

The study will consist of 7 clinic visits, including Screening/Baseline Visit 1 (Day 0,
which is anticipated to be the same date as Visit 6 in F202), visits after 1, 3, 6, 9, and
12 months of treatment (Visits 2-6), and a Follow-up Visit (Visit 7) scheduled within one
month after stopping study drug treatment.

Primary:

The primary objective of the study is to evaluate the long-term safety of TNX-102 SL tablets
taken daily at bedtime over 12 months in patients with FM who have completed Study
TNX-CY-F202

Secondary:

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

Inclusion Criteria:

1. The patient met all prior inclusion and exclusion requirements for Study F202
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.

2. The patient completed expected dosing in F202 defined as taking study medication up
to Week 12, with at least 70% compliance with medication usage (based on responses
from daily IVRS calls recorded during the F202 study) and no major protocol
violations.

3. The patient has provided written informed consent to participate in this extension
protocol.

Exclusion Criteria:
We found this trial at
13
sites
Seattle, Washington 98122
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Brooksville, Florida 34601
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbus, Ohio 43212
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Denver, Colorado 80239
?
mi
from
Denver, CO
Click here to add this to my saved trials
Frederick, Maryland 21702
?
mi
from
Frederick, MD
Click here to add this to my saved trials
Greer, South Carolina 29650
?
mi
from
Greer, SC
Click here to add this to my saved trials
Jackson, Mississippi 39202
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Mechanicsburg, Pennsylvania 17055
?
mi
from
Mechanicsburg, PA
Click here to add this to my saved trials
Middleburg Heights, Ohio 44130
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
North Dartmouth, Massachusetts 02747
?
mi
from
North Dartmouth, MA
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Worcester, Massachusetts 01610
?
mi
from
Worcester, MA
Click here to add this to my saved trials