EXIST3 Everolimus Drug Trial

The Washington University Tuberous Sclerosis Center is participating in the Novartis-sponsored clinical drug trial: “A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures (EXIST-3)”. The goal of this trial is to test the efficacy and safety of a drug with a novel mechanism of action (mTOR inhibitor) for drug-resistant epilepsy in TSC patients.

For additional information, call Olga Novak, clinical research coordinator at 314-454-6120, or see the Clinical Trials.gov websiteThis trial is now closed to enrollment.

Cannabidiol (CBD) Drug Trial

The Washington University Tuberous Sclerosis Center is participating in the GW Pharmaceuticals-Greenwich Biosciences industry-sponsored clinical drug trial: “A Double-blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients with Tuberous Sclerosis Complex who Experience Inadequately-Controlled Seizures (GWPCARE6)”. The goal of this trial is to test the efficacy and safety of cannabidiol, a component of marijuana, for drug-resistant epilepsy in TSC patients.

For additional information, call Olga Novak, clinical research coordinator at 314-454-6120, or see the Clinical Trials.gov website. This trial is now closed to enrollment.

PREVeNT Drug Trial

The Washington University Tuberous Sclerosis Center is participating in the NIH-sponsored, multicenter trial, Preventing Epilepsy using Vigabatrin in infants with Tuberous Sclerosis Complex (PREVeNT). Unlike most clinical drug trials for epilepsy that treat seizures after they’ve started, the goal of this potentially ground-breaking study is to determine whether early treatment with vigabatrin in infants prior to the onset of seizures can improve cognitive and developmental outcomes and can delay or prevent the development of epilepsy in TSC.

For additional information, call Olga Novak, clinical research coordinator at 314-454-6120, or see the Clinical Trials.gov website.

TSC-STEPS Drug Trial

The Washington University Tuberous Sclerosis Center is participating in the FDA-sponsored, multicenter trial, Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study (TSC-STEPS).  The purpose of this placeo-controlled clinical drug trial is to determine whether early treatment with the mTOR inhibitor sirolimus in infants prior to the onset of seizures can improve prevent the development of epilepsy and neurodevelopmental deficits in TSC.

For additional information, call Olga Novak, clinical research coordinator at 314-454-6120, or see the Clinical Trials.gov website.