Table of Contents
- Trial overview
- OCD efficacy study
- Long-term OCD safety study
- Glioblastoma study
- Main outcomes and endpoints
- Patient glossary
Trial overview
The clinical trials in this dataset study Troriluzole in two main conditions: obsessive compulsive disorder (OCD) and glioblastoma (GBM).[1][2][3]
All three studies are interventional trials, which means the researchers gave a study treatment and watched what happened.[1][2][3]
Two trials are Phase 3 studies in OCD, and one trial is a Phase 4 study in GBM.[1][2][3]
OCD efficacy study
NCT04693351 studied Troriluzole as an added treatment for people with Obsessive Compulsive Disorder who had an inadequate response to their current OCD treatment.[1]
This was a Phase 3 trial with an enrollment of 700 participants and a status of completed.[1]
The study compared Troriluzole with placebo, which is a look-alike treatment used for comparison, and it included oral Troriluzole doses of 100 mg and 140 mg.[1]
The main goal was to see whether Troriluzole improved obsessive-compulsive symptoms more than placebo, using change in the Y-BOCS total score from baseline.[1]
Long-term OCD safety study
NCT04708834 studied the long-term safety and tolerability of Troriluzole as adjunctive therapy in people with OCD who had not responded well enough to SSRIs, clomipramine, venlafaxine, or desvenlafaxine.[2]
This was also a Phase 3 study, with an enrollment of 1200 participants and a completed status.[2]
Participants received oral Troriluzole at 100 mg or 140 mg.[2]
The study measured safety and tolerability by tracking serious adverse events, adverse events that led to stopping treatment, events judged related to the study medication, and clinically significant laboratory abnormalities.[2]
Glioblastoma study
NCT03970447 studied Troriluzole in Glioblastoma (GBM), a fast-growing brain cancer.[3]
This was a Phase 4 interventional study with an enrollment of 1845 participants and a status of authorised.[3]
The trial tested multiple regimens in newly diagnosed and recurrent GBM and aimed to find experimental therapies that improve overall survival.[3]
The study also aimed to learn whether certain patient subtypes or biomarkers could help identify who may benefit most, and then confirm promising findings in an expansion stage designed to support a new drug application.[3]
Main outcomes and endpoints
In the OCD efficacy study, the main endpoint was the change in Y-BOCS total score from baseline, which shows whether obsessive-compulsive symptoms improved.[1]
In the long-term OCD safety study, the main endpoint focused on safety and tolerability, including serious adverse events, treatment stops caused by side effects, side effects linked to the study drug, and important lab changes.[2]
In the GBM study, the main endpoint was overall survival, defined as the time from randomization to death from any cause.[3]
Patient glossary
Adjunctive therapy means a treatment added to the treatment a person is already receiving.[1][2]
Baseline means the starting point before treatment changes are measured.[1]
Clinical trial means a research study in people that tests a medical treatment or strategy.[1][2][3]
Enrollment means the number of people planned or included in a study.[1][2][3]
Placebo means a treatment that looks like the study drug but is used for comparison.[1]
Randomization means participants are assigned to a study group by chance.[3]
Safety and tolerability means how well people can take a treatment without too many harmful effects.[2]
Serious adverse event means a serious health problem that happens during a study.[2]
Subtype means a smaller group within a disease that may behave differently from other groups.[3]
Y-BOCS is a scale used to measure obsessive-compulsive symptoms.[1]
