Protocol for a single patient therapy plan: A randomised, double‐blind, placebo‐controlled N‐of‐1 trial to assess the efficacy of cannabidiol in patients with intractable epilepsy

Abstract Aim: This paper describes the use of the single patient therapy plan (SPTP). The SPTP has been designed to assess the efficacy at an individual level of a commercially available cannabinoid product, cannabidiol, in reducing seizure frequency in paediatric patients with intractable epilepsy. Methods: The SPTP is a randomised, double‐blind, placebo‐controlled N‐of‐1 trial designed to assess the efficacy of treatment in a neurology outpatient setting. The primary objective of the SPTP is to assess the efficacy of cannabidiol in