Treatment of Drug Resistant Epilepsy

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The main goal of this study is to provide treatment with cannabidiol (CBD) to children with drug resistant epilepsy through a Physician Expanded Access Investigation New Drug protocol. As the controlled therapeutic use of CBD in children is novel, the primary objective of this study is to evaluate the safety and efficacy of CBD when administered as adjunctive therapy in children that have exhausted the majority of FDA approved antiepileptic drug treatment options.

Details

• Lead Sponsor: University of Florida
• Collaborator: James and Esther King Biomedical Research Program
• Treatments: Cannabidiol

Criteria

Inclusion Criteria:

• history of a trial of at least four drugs, including one trial of a combination of two concomitant drugs, without successful seizure control.

• Vagal nerve stimulation: VNS must be on stable settings for a minimum of 1 month,

• RNS deep brain stimulation, or

• the ketogenic diet can be considered equivalent to a drug trial and must be on a stable ratio for a minimum of 3 months.

• anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment.

• 4 clinically countable seizures per month: Seizure history to include a documented history of generalized seizures (drop attacks, atonic, tonic-clonic and/or myoclonic), focal seizures without loss of consciousness with a motor component, focal seizures with loss of consciousness, or focal seizures with secondary generalization,

Exclusion Criteria:

• Use of CBD based product within the previous 30 days.

• Initiation of felbamate within 6 months.

• Allergy to CBD or any cannabinoid.

• Unable to comply with study visits/requirements.

• Diagnosis of Dravet Syndrome or Lennox-Gastaut syndrome will be excluded completely from this trial.

• Cannabidiol is contraindicated in pregnancy. Female subjects who are pregnant will be excluded from the study. If a female subject is able to become pregnant, she will be given a serum pregnancy test before entry into the study. Female subjects will be informed not become pregnant while taking cannabidiol. Female subjects must tell the investigator and consult an obstetrician or maternal-fetal specialist if they become pregnant during the study.