Full Study Title: 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 seizure

What is this study about?

This study is looking at how effective and safe cannabidiol (also known as CBD) is in people 1 year to 65 years old living with Tuberous Sclerosis Complex (TSC). In this study, CBD would be given in addition to their current anti-seizure medications.

The study will look at a number of outcomes including whether people taking CBD have less seizures or become seizure free, and whether they have a change in their mood or quality of life.

People will record their seizure information, details on how they’ve taken their medications, and any side effects they experience by using a paper diary and answering questions by telephone.

Who can participate?

To be part of this study, people must:

  • Be between 1 and 65 years old
  • Have a diagnosis of TSC
  • Be on the same treatment for their seizures for at least one month 
  • Be willing for their primary care practitioner and/or legal authorities to be notified of their participation in the study, if it is required by state law

People cannot be part of this study if they:

  • Have had epilepsy surgery within six months of being screened for this study
  • Are taking felbamate for less than a year, or taking an mTOR inhibitor
  • Have impaired liver function
  • Are pregnant
  • Currently are using or previously used recreational or medicinal cannabis or CBD-based medications within the last three months and are unwilling to not use the them during the study

How can I participate?

  • The first step is to see if the study is right for you at a screening visit with a healthcare provider and a baseline period of four weeks.
  • If you are eligible for this study, you will be randomly assigned by chance (like the flip of a coin) to receive either:
    • The study drug, CBD, at dose of 25 mg/kg/day
    • The the study drug, CBD, at dose of 50 mg/kg/day
    • A placebo at a dose of 25 mg/kg/day
    • A placebo at a dose of 50 mg/kg/day
  • People in all four groups will be given their assigned treatment for 16 weeks.
  • During the course of the study, you will have several check-ups with your healthcare provider. Some or all of the following will be done at these visits: physical exam, blood and urine sample collection, review of medications, discussion of seizure frequency, and discussion of your mood and how you are feeling.
  • Following the 16-week blinded phase, all participants will have the opportunity to receive CBD for an initial period of one year (this is called the open label extension phase). This phase is to evaluate long-term effects of CBD.

Are there risks?

  • With all trial drugs and devices, there is the chance the treatment may not help a person’s seizures.
  • One of the areas that will be monitored throughout is liver function, due to the potential risk of injury to the liver from medicines. If the participant is unable to tolerate treatment with CBD, the study team will help them taper off the medication.

Contact Greenwich Biosciences Medical Information for details on how to join this trial via email (medinfo@greenwichbiosciences.com) or telephone at 833-GBIOSCI (833-424-6724).