MAGNET

• Research type

  Research Study

• Full title

  A Multi-arm, Adaptive, Group-sequential trial NETwork to evaluate drug efficacy in patients with Amyotrophic Lateral Sclerosis (ALS)

• IRAS ID

  1005268

• Contact name

  Leonard van den Berg

• Contact email

  magnet@tricals.org

• Sponsor organisation

  Stichting TRICALS Foundation

• Eudract number

  2020-000579-19

• ISRCTN Number

  ISRCTN15671139

• Research summary

  The aim of this study is to simultaneously investigate the efficacy and safety of multiple drugs for ALS (Amyotrophic Lateral Sclerosis). We do this by using so-called 'study arms'. Each study arm investigates the efficacy and safety of one drug or a combination of drugs. Once it is clear which arm of the study you are participating in, you will be assigned a drug or placebo by drawing lots. A placebo is a substance without an active substance, a 'fake substance'.
  Currently one arm is active that investigates the effect of lithium carbonate vs placebo in ALS.
  Lithium is a substance currently registered for use in bipolar disorders. This is a psychiatric disease that causes severe mood swings. Lithium affects multiple biological mechanisms involved in ALS. Previous research has shown that the drug is not effective in all patients with ALS, but may be beneficial in patients with a variation in the UNC13A gene (1 in 6 patients has this variation). Lithium is not currently being prescribed for ALS outside of this study.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  22/EE/0132

• Date of REC Opinion

  27 Jul 2022

• REC opinion

  Further Information Favourable Opinion