Clinical Trial of Troriluzole in Generalized Anxiety Disorder
Brief description of study
Generalized
Anxiety Disorder is defined as persistent and excessive worry about a number of
different things which can lead to significant distress or impairment in social
or occupational functioning.
This study involves a drug called troriluzole, which is being developed for the treatment of Generalized Anxiety Disorder (GAD). People with
GAD may be overly concerned about money, health, family, work or other issues
and find it difficult to control their worry.
Troriluzole is thought to
work through its main by-product (called riluzole) that is thought to have an
effect on mechanisms causing GAD symptoms.
Troriluzole is an
“investigational” drug, which means that the drug has not been approved for use
by regulatory authorities (such as the U.S. Food and Drug Administration [FDA])
outside of research studies like this one. This drug is therefore considered
experimental.
The goals of this study are:
1.
To evaluate the
difference in how troriluzole works
compared to placebo on your GAD symptoms.
2.
To evaluate how safe
and how well tolerated troriluzole is
when administered as a dose of 100 mg twice a day.
3. To evaluate how troriluzole
works compared to placebo using scales that assess other aspects of your
health that may be affected by GAD.
Detailed description of study
This study is divided into 3 phases. Phase 1 is a screening phase, where you will not receive any study drug, but you
will work with the study doctor (Principal Investigator) and the study staff at
the site to evaluate your disorder and make sure you meet all the study
criteria to receive study drug. If you
qualify to continue in the study, you will enter Phase 2 of the study which is
the Randomization Phase. It will be up to 8 weeks and involves two (2) daily
doses of either troriluzole or
placebo. A placebo is a dummy capsule
that looks similar to troriluzole, but
does not contain the active ingredient. Phase 3 is the Extension Phase and
involves a daily dose of troriluzole 100
mg twice a day and will be up to 24 weeks in duration. After completing this study (at any time) you
will be asked to come back to the study center 2 weeks after you finish the
study drug for final assessments.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
anxiety,GAD
-
Age: Between 18 Years - 65 Years
-
Gender: All
Updated on
13 Nov 2019.
Study ID: 832595