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Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY (EpiTALY)

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Jazz Pharmaceuticals

Status

Not yet enrolling

Conditions

Tuberous Sclerosis Complex
Dravet Syndrome
Lennox Gastaut Syndrome

Treatments

Drug: Epidiolex 100 mg/mL Oral Solution

Study type

Observational

Funder types

Industry

Identifiers

NCT05485831
JZP926-525

Details and patient eligibility

About

This is a prospective, observational study on approximately 70-100 Real World participants affected by LGS, DS, or TSC treated with Epidyolex® as prescribed in the summary of product characteristics. The eligible participants are expected to participate in the study for a duration of 52 weeks of treatment.

Full description

This observational study evaluates a Real-World population of children and adult participants affected by LGS, DS, and TSC and the effect of therapy with Epidyolex® administered according to clinical practice on epileptic symptoms. The study will assess specific scales, questionnaires, and the satisfaction of the caregivers and the participants/tutors.

Enrollment

100 estimated patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Lennox Gastaut, Dravet Syndrome, and Tuberous Sclerosis Complex
Description:
Participants ≥2 years of age diagnosed with LGS, DS, and TSC.
Treatment:
Drug: Epidiolex 100 mg/mL Oral Solution

Trial contacts and locations

15

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Central trial contact

Clinical Trial Disclosure & Transparency

Data sourced from clinicaltrials.gov

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