Clinical Trial of Troriluzole in Generalized Anxiety Disorder

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

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