A Phase 4 interventional study of Cannabidiol Oral Solution [Epidiolex] in Tuberous Sclerosis Complex Associated Neuropsychiatric Disease, sponsored by Jazz Pharmaceuticals. Completed at 19 sites in 4 countries. Open to participants aged 1 Year to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Jazz Pharmaceuticals · Phase 4, Interventional, and Treatment
The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.
766 studies on the registry are indexed under Seizures; 136 are open to participants now.
This study's enrollment of 79 is above the median of 64 across 519 interventional studies indexed under Seizures.
Browse Seizures studies →Jazz Pharmaceuticals is the lead sponsor of 173 studies on the registry; 18 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 32 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Is within the required age range at the time of signing (or at the time of the participant's parent(s)/Legally Authorized Representative (LAR) signing) the or providing assent (as applicable):
Is taking 1 or more anti-seizure medicine (ASM) at a dose that has been stable for at least 4 weeks prior to Screening.
Is male or female
Male participants:
Female participants:
A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Cannabidiol Oral Solution [Epidiolex]
100 mg/ml Cannabidiol Oral solution
Also known as: Epidiolex
Change in the most problematic behavior Numerical Rating Score (NRS) score within the TAND-SQ
Time frame: Baseline, Week 13, Week 26, Week 52
Change in Tuberous Sclerosis Complex Associated Neuropsychiatric Disorders Self-report, Quantified Checklist (TAND-SQ) score
Time frame: Baseline, Week 13, Week 26, Week 52
Change in Aberrant Behavior Checklist (ABC) score
Time frame: Baseline, Week 13, Week 26, Week 52
Change in Child Behavior Checklist (CBCL) score
Time frame: Baseline, Week 26, Week 52
Change in Adult Behavior Checklist (ABCL) score
Time frame: Baseline, Week 26, Week 52
Change in Adult Self-Report (ASR) score
Time frame: Baseline, Week 26, Week 52
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) domains score
Time frame: Baseline, Week 26, Week 52
Change in sleep characteristics using the Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Baseline, Week 26
Change in sleep characteristics using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Week 26
Change in executive function using Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Baseline, Week 26
Change in caregiver-reported assessment of Quality of Life (QOL) using Pediatric Quality of Life Survey Family Impact Module (PedsQL FIM)
Time frame: Baseline, Week 26
Change in caregiver-reported assessment of family functioning using Pediatric Quality of Life Survey Family Impact Module (PedsQL FIM)
Time frame: Baseline, Week 26
Change in assessment of QOL using Pediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline, Week 26
Change in caregiver impression of overall severity of symptoms (behavior and seizure control) using the Caregiver Global Impression of Severity (CareGI-S)
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Change in participant impression of overall severity of symptoms (behavior and seizure control) using the Patient Global Impression of Severity (PGI-S)
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Change in clinician impression of overall severity of symptoms (behavior and seizure control) using the Clinician Global Impression of Severity (CGI-S)
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Retention Rate
Retention rate is the number of participants continuing with CBD-OS treatment over total accrued participants
Time frame: Baseline, Week 13, Week 26, Week 52
Number of participants considered treatment responders
Treatment responders will be reported as those with a 25%, 50%, 75% and 100% reduction in seizure frequency from baseline
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Change in number of seizure-free days
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Number of participants experiencing a worsening, no change, or improvement in seizure frequency
Number of participants who experience a change in seizure frequency from baseline defined as: 1. worsening (\>25%) 2. no change (-25 to + 25%) 3. improvement (-25% to -50%, ≥-50% to -75%, ≥-75%)
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Change in ideation score per the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Change in number of suicide attempts per the C-SSRS
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Change in ideation score per the Children's C-SSRS
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Change in number of suicide attempts per the Children's C-SSRS
Time frame: Baseline, Week 4, Week 13, Week 26, Week 52
Number of participant inpatient hospitalizations due to epilepsy
Time frame: Up to Week 52
Number of withdrawals due to Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 52
Plan to share: Yes — In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy, contact clinicaldatasharing@jazzpharma.com
Data sharing details ↗ · www.jazzpharma.com
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cannabidiol