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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
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
Male or female, aged 2-17 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 a man who can father children and will use contraception.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Spike Wave Index
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,325 Total Patients Enrolled
Northwell HealthLead Sponsor
457 Previous Clinical Trials
470,225 Total Patients Enrolled
Greenwich BiosciencesIndustry Sponsor
2 Previous Clinical Trials
117 Total Patients Enrolled

Media Library

Epidiolex (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04721691 — Phase 1
Status Epilepticus of Slow-Wave Sleep Research Study Groups: IP, Placebo
Status Epilepticus of Slow-Wave Sleep Clinical Trial 2023: Epidiolex Highlights & Side Effects. Trial Name: NCT04721691 — Phase 1
Epidiolex (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04721691 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation still accepting participants?

"Indeed, the clinicaltrial.gov listing confirms that this medical trial is currently enrolling participants. It was initially published on March 10th 2021 and most recently edited on April 5th 2022. The research team requires a total of 34 individuals from one site to participate in the study."

Answered by AI

How many participants are enrolled in this clinical research?

"Affirmative. Information located on clinicaltrials.gov confirms that this experiment, which was posted initially on March 10th 2021, is currently enrolling participants. Approximately 34 individuals need to be enrolled from 1 medical centre."

Answered by AI

What prior studies have been conducted on the utility of IP?

"Presently, 79 clinical trials for IP are ongoing. Of these studies, 16 have reached Phase 3 and 290 distinct sites are running the trial globally with a focus in Ribeirao Preto and Sao Paulo."

Answered by AI

Are there any health risks associated with IP treatment?

"Our experts at Power rated IP's safety as a 1, indicating that there is limited evidence of its efficacy and it has yet to be well-tested."

Answered by AI

Is there an opportunity to be involved in this clinical experiment?

"This research initiative is in search of 34 participants between the ages of two and seventeen who have been diagnosed with petit mal status. In addition to being willing and able to comply with study procedures, potential candidates should possess general health stability without any imminently requiring hospitalization due to seizures, alongside a signed consent form. For male or female patients of reproductive age, they must utilize an approved birth control method one month prior to screening as well as throughout their participation in the trial; males are additionally mandated use condoms during sexual intercourse for contraceptive purposes."

Answered by AI

Is the participant eligibility for this experiment limited to individuals over 60 years of age?

"The age range for this medical trial is between 2 and 17, as dictated by the eligibility criteria."

Answered by AI
~7 spots leftby Jan 2025