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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-24

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lennox Gastaut Syndrome Dravet Syndrome Tuberous Sclerosis Complex

Keywords

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seizures Epidyolex cannabidiol oral solution

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lennox Gastaut, Dravet Syndrome, and Tuberous Sclerosis Complex

Participants ≥2 years of age diagnosed with LGS, DS, and TSC.

Epidiolex 100 mg/mL Oral Solution

Intervention Type DRUG

As prescribed in routine clinical practice in Italy.

Interventions

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Epidiolex 100 mg/mL Oral Solution

As prescribed in routine clinical practice in Italy.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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Clinical Trial Disclosure & Transparency

Role: CONTACT

Phone: 215-832-3750

Email: [email protected]

Other Identifiers

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JZP926-525

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Lennox Gastaut, Dravet Syndrome, and Tuberous Sclerosis Complex

Epidiolex 100 mg/mL Oral Solution

Interventions

Epidiolex 100 mg/mL Oral Solution

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Advice Pharma Group srl

Jazz Pharmaceuticals

Responsible Party

Locations

Policlinico Sant'Orsola di Bologna

NPI AOU Mater Domini Università Magna Graecia

Università degli studi "G. D'annunzio" Chieti

Azienda Ospedaliera Universitaria Meyer Neurologia Pediatrica

Istituto Gaslini Neurologia Pediatrica e Malattie Muscolari

AOU Gaetano Martino

Centro Regionale Epilessia - ASST Santi Paolo e Carlo

ASST Grande Ospedale metropolitano Niguarda

Azienda Ospedaliera Universitaria Federico II

AOU Maggiore della Carità di Novara

AOU di Padova

Policlinico Tor Vergata

IRCCS Ospedale Pediatrico Bambin Gesù

Fondazione Policlinico Universitario Agostino Gemelli - IRCCS-NPI

Azienda Ospedaliero Universitaria Sant'Andrea

Ospedale Casa del sollievo e della sofferenza

AOU Città della Salute PO Molinette

Azienda Ospedaliero Universitaria delle Marche

Countries

Central Contacts

Clinical Trial Disclosure & Transparency

Other Identifiers

JZP926-525