Cannabidiol for treating seizures caused by tuberous sclerosis complex

NICE state (1):

Cannabidiol (CBD) is recommended as an add-on treatment option for seizures caused by tuberous sclerosis complex in people aged 2 years and over, only if:

• their seizures are not controlled well enough by 2 or more antiseizure medications (either used alone or in combination) or these treatments were not tolerated
• seizure frequency is checked every 6 months, and cannabidiol is stopped if the frequency has not fallen by at least 30% compared with the 6 months before starting treatment
• the company provides cannabidiol according to the commercial arrangement

The NICE committee state that:

• "...usual care for seizures caused by tuberous sclerosis complex includes antiseizure medications. Cannabidiol is licensed as an add-on treatment option for people aged 2 years and over. The company has positioned it for use when seizures are not controlled well enough by 2 or more antiseizure medications or when these were not tolerated.
• clinical trial evidence shows that cannabidiol plus usual care reduces seizure frequency and increases the number of seizure-free days compared with placebo plus usual care..."

Notes:

• study evidence shows that in patients with tuberous sclerosis (TSC) (2)
  • long-term add-on CBD treatment was well tolerated and sustainably reduced seizures through 48 weeks, with most patients/caregivers reporting global improvement
  • treatment with CBD produced a sustained reduction in TSC-associated seizures, including countable focal and generalized seizures but excluding absence, myoclonic, focal sensory, and infantile/epileptic spasms, as well as in total seizures, which included all of the above-mentioned seizures types. In the randomized, placebo-controlled phase of the trial, CBD produced an approximate 40% reduction in the frequency of seizures associated with TSC

Reference:

• NICE (March 2023). Cannabidiol for treating seizures caused by tuberous sclerosis complex
• Thiele EA, Bebin EM, Filloux F, Kwan P, Loftus R, Sahebkar F, Sparagana S, Wheless J. Long-term cannabidiol treatment for seizures in patients with tuberous sclerosis complex: An open-label extension trial. Epilepsia. 2022 Feb;63(2):426-439.