NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Active Not RecruitingN/A

Sponsor: Jazz Pharmaceuticals

Conditions: Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex

Interventions: Epidiolex 100 mg/mL Oral Solution

Countries: Italy

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.

Eligibility overview

Sex: ALL

Age: 2 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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.

Locations (18)

Bologna, Italy
Catanzaro, Italy
Chieti, Italy
Florence, Italy
Genova, Italy
Messina, Italy
Milan, Italy
Milan, Italy
Naples, Italy
Novara, Italy
Padova, Italy
Roma, Italy
Roma, Italy
Roma, Italy
Roma, Italy
San Giovanni Rotondo, Italy
Torino, Italy
Torrette, Italy