Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).

Who is this study for? Patients with Electrical Status Epilepticus of Slow-Wave Sleep

What treatments are being studied? Epidiolex

Status: Completed

Location: See location...

Intervention Type: Drug, Other

Study Type: Interventional

Study Phase: Phase 1

SUMMARY

This study aims to assess the efficacy of Epidiolex in patients with ESES. ESES is characterized by sleep potentiated spikes with a spike index greater than 85% (conventional definition) and 50% (new definition)1. Several drugs including: steroids, intravenous Gama globulin, Clobazam, other benzodiazepines, Valproic acid, and other anti-epileptic drugs have been tried with mixed benefits2,3. Cannabidiol (CBD) would provide a novel mechanism of action to assess for its efficacy in this population. This will be a double-blind placebo-controlled crossover clinical trial.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 2

Maximum Age: 17

Healthy Volunteers: f

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⁃ In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Male or female, aged 2-17 years old

• In good general health as evidenced by medical history or diagnosed with ESES. Good health in relation to this study is understood as stable without current seizures requiring immediate hospitalization.

• Ability to take oral medication and be willing to adhere to the Epidiolex/Placebo regimen

• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 month after the end of oral Epidiolex administration

• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Locations

United States

New York

Northwell Health

Lake Success

Time Frame

Start Date: 2021-03-10

Completion Date: 2024-01-17

Participants

Target number of participants: 16

Treatments

Active_comparator: IP

Epidiolex (Cannabidiol) is a colorless to yellow solution in a 100mL vial that is to be administered with a 5mL syringe.The starting dosage is 2.5 mg/kg twice daily, or 5 mg/kg/day. After one week, the dosage can be increased to a maintenance dosage of 5mg/kg twice daily, or 10 mg/kg/day. Patients who are tolerating Epidiolex at 10mg/kg per day and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance. Dosage of 10mg/kg twice daily (20mg/kg/day), in weekly increments of 2.5 mg/kg twice daily(5mg/kg/day), as tolerated. For patients in whom a more rapid titration from 10 mg/kg/day to 20 mg/kg/day is warranted, the dosage may be increased to no more frequently than every other day administration of the 20 mg/kg/day. Dosage resulted in somewhat greater reductions in seizure rates than the recommended maintenance dosage of 10 mg/kg/day, but with an increase in adverse reactions.

Placebo_comparator: Placebo

Placebo is a colorless to yellow solution in a 100mL vial that is to be administered with a 5mL syringe. The starting dosage is 2.5 mg/kg twice daily, or 5 mg/kg/day. After one week, the dosage can be increased to a maintenance dosage of 5mg/kg twice daily, or 10 mg/kg/day. Patients who are tolerating Placebo at 10mg/kg per day and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance. Dosage of 10mg/kg twice daily (20mg/kg/day), in weekly increments of 2.5 mg/kg twice daily(5mg/kg/day), as tolerated. For patients in whom a more rapid titration from 10 mg/kg/day to 20 mg/kg/day is warranted, the dosage may be increased to no more frequently than every other day administration of the 20 mg/kg/day. Dosage resulted in somewhat greater reductions in seizure rates than the recommended maintenance dosage of 10 mg/kg/day, but with an increase in adverse reactions.

Related Therapeutic Areas

Myoclonic Epilepsy

Status Epilepticus

Lennox-Gastaut Syndrome (LGS)

Epilepsy with Myoclonic-Atonic Seizures

Seizures

Epilepsy

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