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Epidiolex for Tuberous Sclerosis Complex (EpiCom Trial)
Phase 4
Recruiting
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 13, week 26, week 52
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial investigates how adding EPIDIOLEX to existing treatments affects behavior and other outcomes in people aged 1 to 65 with TSC who have seizures. The medication aims to reduce seizure frequency and severity by influencing brain chemicals. Epidiolex, a cannabidiol (CBD) product, has been studied for its safety and effectiveness in treating seizures related to tuberous sclerosis complex (TSC).
Who is the study for?
This trial is for individuals aged 1 to 65 with tuberous sclerosis complex (TSC) who have seizures. Participants must be on stable anti-seizure medication, not have used CBD-OS recently, and agree to consistent contraceptive use if applicable. They cannot join if they've had certain medical conditions or treatments that could affect the study, or a history of substance abuse.
What is being tested?
The study tests Epidiolex (Cannabidiol Oral Solution) as an additional treatment for TSC-related seizures and behavioral issues. It aims to see how adding this solution affects patients' behavior and other related outcomes alongside their current seizure medications.
What are the potential side effects?
Epidiolex may cause side effects such as sleepiness, decreased appetite, diarrhea, fever, vomiting, fatigue. More serious but less common effects include thoughts of suicide or liver problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4, week 13, week 26, week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 13, week 26, week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants considered treatment responders
Number of participants experiencing a worsening, no change, or improvement in seizure frequency
Retention Rate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cannabidiol Oral SolutionExperimental Treatment1 Intervention
Participants who will receive the Cannabidiol Oral Solution (CBD-OS) titrated up to a dose of 12.5 mg/kg administered twice daily for a total dose of up to 25 mg/kg/day for 26 consecutive weeks. Participants will have the option to continue receiving the CBD-OS for an additional 26 weeks, for a total of 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol Oral Solution [Epidiolex]
2020
Completed Phase 3
~20
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Tuberous Sclerosis Complex (TSC) Neuropsychiatric Disorder include medications like Epidiolex (Cannabidiol), which modulates the endocannabinoid system to reduce seizure frequency and severity. This is particularly important for TSC patients as seizures are a prevalent and debilitating symptom.
Other treatments may include antiepileptic drugs (AEDs) such as topiramate, which stabilizes neuronal membranes and inhibits certain neurotransmitter receptors to prevent seizures. Additionally, behavioral therapies and medications targeting specific neuropsychiatric symptoms, such as ADHD or anxiety, are often used.
These treatments are essential for improving the quality of life in TSC patients by managing both seizures and associated neuropsychiatric symptoms.
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Who is running the clinical trial?
Jazz PharmaceuticalsLead Sponsor
249 Previous Clinical Trials
34,766 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious health condition that is not epilepsy.I started taking felbamate less than a year ago.I haven't been sick with anything other than epilepsy in the last 4 weeks.My tumor growth is related to my TSC condition.My liver is not working well.I am within the age range required for this study.I have been diagnosed with TSC and have a history of seizures.I have never taken CBD-OS treatment or stopped it at least 3 months ago.I am either male or female.I am a man and will use birth control and not donate semen during the study.I am not pregnant or breastfeeding and follow specific birth control guidelines.My epilepsy treatment has been the same for the last 4 weeks.I have been on a stable dose of seizure medication for at least 4 weeks.I had major epilepsy surgery that could affect outcome assessments.
Research Study Groups:
This trial has the following groups:- Group 1: Cannabidiol Oral Solution
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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