Title of Project | A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder |
Objective | This study investigates the addition of troriluzole as an adjunctive therapy to current OCD medication in adults (18-65 years) with OCD who have failed to respond adequately to their current pharmacotherapy |
Eligibility Criteria | Eligible participants will have been diagnosed with Obsessive Compulsive Disorder (OCD) and have had an inadequate response to at least one OCD medication (including current medication). Patients must currently be on an SSRI for their OCD. Eligible participants include males and females between the ages of 18-65. Pregnant women will be excluded from the study as the effect of this medication on unborn children is unknown. Participants must be able to communicate verbally and read in English. |
Potential Risks | Like all medications, troriluzole is also associated with side effects, however not all side effects are yet known. In previous clinical trials involving troriluzole, there have been no side effects reported at frequencies greater than 1 in 10 patients. Common reported side-effects include: headaches, dizziness, fatigue, nausea, common cold, Upper Respiratory Tract Infection, Urinary Tract Infection, diarrhea, drowsiness and insomnia. There may be possible side effects from blood drawing, including faintness, inflammation of the vein, pain, bruising, or bleeding at the site of puncture. There is also a slight possibility of infection. Additionally, there may be unknown risks to a pregnancy, embryo, or fetus if the subject or their female partner becomes pregnant. |
End date | July 31, 2022 |
Study Involvement | The study takes approximately 14-18 weeks overall to complete with 8 study visits during this time. If participants are interested, they are also able to continue with the study afterwards through an open-label 48 week study. |
Contact | Email our Research Assistant at [email protected] , call us at 905-921-7644 or check out our website at http://www.macanxiety.com/current-research/ for more information. |
Background:
Although SSRIs and clomipramine are approved treatments for Obsessive Compulsive Disorder (OCD), up to 60% of patients have an inadequate response to pharmacological treatment. Recent findings have revealed that troriluzole works through a compound (called riluzole) which is thought to target processes in the brain that cause the obsessions and compulsions involved with OCD. Troriluzole was developed to be a safer, more convenient form of riluzole, which is a U.S. Food and Drug Administration (FDA) and Health Canada-approved medication for ALS, also known as Lou Gehrig’s disease. Troriluzole is an “investigational” drug, which means that the drug has not been approved for use by regulatory authorities (such as the FDA or Health Canada) outside of research studies like this one. It is currently being developed as an adjunctive medication to standard of care (SOC) treatments in patients who are not responding well to their current OCD medication. This is a multi-site, phase 3 clinical trial, evaluating the safety, tolerability, and efficacy of troriluzole as a drug added to patients’ current OCD medication. This study investigates the addition of troriluzole as an adjunctive therapy to current OCD medication in adults (18-65 years) with OCD who have failed to respond adequately to their current pharmacotherapy. It is a randomized, placebo-controlled study. Individuals who are on a stable medication for OCD and are demonstrating an inadequate response with be randomized to receive either placebo or troriluzole. Individuals will be assessed at regular intervals during the treatment phase to monitor treatment response, changes in symptom severity and the occurrence of any side-effects. The primary objective of the study is to evaluate the efficacy of troriluzole as adjunctive therapy compared to placebo in subjects with OCD who have had an inadequate response to their current OCD treatment. The secondary objectives of this study are to assess the safety and tolerability of troriluzole, relative to placebo, in subjects with treatment-resistant OCD. The outcomes from this study will make a significant contribution to our understanding of the efficacy of this novel medication in individuals who have OCD that is refractory to pharmacological treatment.