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Cannabinoid

Epidiolex for ESES

Phase 1

Recruiting

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, aged 2-17 years old

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

Must not have

Febrile illness within 1 month of screening

Known allergic reactions to components of the Epidiolex: cannabidiol, sesame seed oil, and sucralose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 20 weeks

Summary

This trial will test if Epidiolex, a drug containing cannabidiol, is effective in treating patients with ESES.

Who is the study for?

This trial is for children and teens aged 2-17 with ESES, a type of seizure disorder worsened by sleep. Participants must be in stable health, able to take oral medication, and use effective contraception if applicable. They can't join if they've used CBD recently, are pregnant or breastfeeding, have had a recent feverish illness, taken experimental drugs within the last 6 months, or are allergic to Epidiolex ingredients.

What is being tested?

The study tests Epidiolex's effectiveness against ESES compared to a placebo. It's double-blind (neither doctors nor patients know who gets what) and crossover (patients switch from drug to placebo at some point), aiming to see if CBD can help where other treatments have had mixed results.

What are the potential side effects?

While not specified here, common side effects of Epidiolex may include drowsiness, decreased appetite, diarrhea, fatigue among others. Allergic reactions could occur in those sensitive to its components like cannabidiol or sesame seed oil.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 2 and 17 years old.

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I can take pills and will follow the medication plan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a fever or febrile illness in the last month.

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I am allergic to Epidiolex, sesame seed oil, or sucralose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of Spike Wave Index

Secondary study objectives

Likert Scale Assessment

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: IPActive Control1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

0 / 4Eligibility criteria met