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Observational study of Epidyolex® for epilepsy in Italy

Observational, Prospective, Multicenter Study of Epidyolex® (Cannabidiol CBD 100 mg/ml) Oral Solution, as Adjunctive Treatment for Seizures Associated With Lennox- Gastaut Syndrome (LGS), Dravet Syndrome (DS) and Tuberous Sclerosis Complex (TSC)

Jazz Pharmaceuticals · NCT05485831

This study is testing how well Epidyolex®, a cannabidiol treatment, works for people with Lennox Gastaut Syndrome, Dravet Syndrome, and Tuberous Sclerosis Complex to see if it helps reduce seizures.

Quick facts

Study typeObservational
Enrollment100 (estimated)
Ages2 Years and up
SexAll
SponsorJazz Pharmaceuticals (industry)
Locations18 sites (Bologna and 17 other locations)
Trial IDNCT05485831 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effects of Epidyolex®, a cannabidiol oral solution, on patients with Lennox Gastaut Syndrome, Dravet Syndrome, and Tuberous Sclerosis Complex. Approximately 70-100 participants, including children aged 2 and older and adults, will be monitored over a 52-week treatment period. The study will assess the impact of the therapy on seizure symptoms and gather feedback from caregivers and participants through various scales and questionnaires.

Who should consider this trial

Good fit: Ideal candidates include adults and children aged 2 years and older diagnosed with Lennox Gastaut Syndrome, Dravet Syndrome, or Tuberous Sclerosis Complex who are starting treatment with Epidyolex®.

Not a fit: Patients currently using recreational or medicinal cannabis or cannabinoid-based products may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Epidyolex® in managing seizures for patients with specific epilepsy syndromes.

How similar studies have performed: Other studies have shown promising results with cannabidiol for epilepsy, suggesting that this approach may be beneficial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Adult patients, and minor patients ≥ 2 years old diagnosed with LGS, DS or TSC.
* Clinical decision, taken by the physician, to initiate Epidyolex®
* Adult participants, parents or legal representatives must be willing and able to give informed consent/assent for participation in the study.

Exclusion Criteria:

* Participants currently using or have used recreational, medicinal cannabis, or cannabinoid-based products within the three months prior to study entry and are unwilling to abstain from these products for the duration of the study.
* Any reason, according to Investigator's judgment, able to compromise compliance with procedures outlined in the study There will not be any other specific exclusion criteria; however, contraindications, special warnings, and precautions for use as detailed in the Summary of Product Characteristics (SmPC) (particularly related to raising of aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], and total bilirubin) will have to be considered by the treating physician.

Where this trial is running

Bologna and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex, seizures, Epidyolex, cannabidiol oral solution

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.