A study of Clemizole HCl in patients with Dravet Syndrome. Version 7

• Research type

  Research Study

• Full title

  A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Patients with Dravet Syndrome (ARGUS Trial)

• IRAS ID

  300846

• Contact name

  Helen Cross

• Contact email

  h.cross@ucl.ac.uk

• Sponsor organisation

  Epygenix Therapeutics

• Eudract number

  2021-003425-30

• Clinicaltrials.gov Identifier

  NCT04462770

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  Dravet Syndrome is a severe childhood onset epilepsy that presents with multiple seizure types commonly resistant to pharmacologic treatment, as well as intellectual disability, behavioral abnormalities, gait and motor dysfunction, and increased mortality. This study will measure the change in the number of seizures subjects taking study drug experience compared with those on placebo. The study will enroll up to 74 patients 2 years and older and it will be performed in the US, Canada and the UK.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  22/NW/0019

• Date of REC Opinion

  13 Apr 2022

• REC opinion

  Further Information Favourable Opinion