An exciting new clinical trial has opened in the UK, focused on TSC-related epilepsy. Named after the Greek goddess of calm seas, the Galene study is seeking people in the TSC community to take part.

Basimglurant – the name of the potential medicine – has shown a lot of promise in the laboratory, with tests showing that it might be useful in:

  • Significantly reducing how long TSC-related epilepsy seizures last
  • Calming the parts of the body that are linked to forming TSC growths in the brain

Basimglurant works differently to existing available medicines for TSC-related epilepsy, meaning that it could be an important future treatment option. For Galene to be successful, it needs participants in the UK TSC community to be part of the study.

How to take part in Galene

You or your loved one must be aged between 5 – 30 years and have TSC-related seizures that aren’t adequately managed by current treatments. Basimglurant is easy to swallow, and can even be sprinkled on things like yoghurt.

Participants will be asked to:

  • Take basimglurant daily
  • Attend seven clinic visits (there are clinics taking part throughout the UK) and provide check-in calls
  • Maintain a daily electronic seizure diary

At the end of the study, anyone who has had positive results will be given the option to continue taking basimglurant.

The study has been very carefully designed to get the most useful results possible, following very strict guidelines and best practice for clinical trials. Galene participants will take basimglurant in addition to their existing treatments – it won’t replace your epilepsy medicines at any point in the study.

What the clinical trial will do

Galene will help us to understand:

  • How good basimglurant is at controlling seizures
  • What the best dose of basimglurant is for TSC-related epilepsy
  • How safe basimglurant is in people with TSC
  • Basimglurant’s impact on quality of life for those with TSC

Basimglurant has already been tested with almost 400 people in other conditions, including Fragile X Syndrome. These tests showed that the potential medicine is safe.

How to take part in Galene

If you’d like to take part in Galene, please contact Noema Pharma – the company running the trial: clinicaltrials@noemapharma.com.

Galene is a study by Noema Pharma. The TSA has no direct involvement in Galene.