Study of Cannabidiol for Drug-Resistant Epilepsies

E

Eric Marsh, MD

Status

Conditions

Drug Resistant Epilepsy

Treatments

Drug: Cannabidiol

Study type

Expanded Access

Funder types

Other

Identifiers

NCT03014440
13-010562

Details and patient eligibility

About

The purpose of this study is to determine if cannabidiol is safe and effective at different doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure frequency. There are only a few open label studies that have demonstrated the safety and tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies were performed either retrospectively or with varying cannabidiol preparations. There are no well-documented studies and completely analyzed data for pediatric epileptic patients.

Sex

All

Ages

1 to 20 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ages between 1 year old and 20 years old, male or female at the first visit, Week -4 (at time informed consent form is signed)

Documentation of a diagnosis of drug-resistant epilepsy as proven by and documented with medical records and/or the following clinical features (must have all 3 of the following):

  • Failure to control seizures despite appropriate trial of 3 or more AEDs at therapeutic doses
  • An intractable childhood epilepsy including, Dravet Syndrome or Lennox-Gastaut Syndrome
  • Must report at least 3 countable (non-countable seizures includes absence and myoclonic) seizures per month
  • Between 1-3 baseline AEDs . Vagus nerve stimulator (VNS), ketogenic diet, and modified Atkins diet do not count towards this limit.
  • VNS must be on stable settings for a minimum of 3 months.
  • If on the ketogenic diet, must be on stable ratio for a minimum of 3 months.

Exclusion criteria

  • Epilepsies associated with neurodegenerative diseases, including neuronal ceroidolipofuscinosis, progressive myoclonus epilepsies, Rasmussen encephalitis, and tumors
  • Epilepsies associated with an inborn error of metabolism, including mitochondrial disorders
  • Felbatol initiated within the past 12 months
  • Use of any Cannabis-related product (including hemp oil) in the past 12 months as assessed by parental questioning.
  • Laboratory values on comprehensive metabolic panel (CMP) and complete blood count (CBC) testing that are Class 3 or higher according to the CTCAE v4.0.
  • Positive pregnancy test.

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems