Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasms

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Rare Diseases

Sclerosis

Seizures

Tuberous Sclerosis

Hamartoma

Neoplasms, Multiple Primary

Syndrome

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Tuberous Sclerosis Complex

Pharmaceutical Solutions

All Drugs and Chemicals

Anticonvulsants

Cannabidiol

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.

Cannabidiol Oral Solution [Epidiolex]

Clinical Trial Disclosure & Transparency

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.

A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex

A Phase 4, Interventional, Multicenter, Open-Label, Single-Arm Study to Assess Behavioral and Other Co-occurring Outcomes Following Treatment With EPID(I/Y)OLEX as Add-on Therapy in Participants (Aged 1 to 65 Years Old) With Seizures Associated With Tuberous Sclerosis Complex

Retention rate is the number of participants continuing with CBD-OS treatment over total accrued participants

Treatment responders will be reported as those with a 25%, 50%, 75% and 100% reduction in seizure frequency from baseline

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%)

Jazz Pharmaceuticals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex	NCT05864846	Tuberous Sclero...	Cannabidiol Ora...	1 Year - 65 Years	Jazz Pharmaceuticals
A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex	NCT05864846	Tuberous Sclero...	Cannabidiol Ora...	1 Year - 65 Years	Jazz Pharmaceuticals
A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex	NCT05864846	Tuberous Sclero...	Cannabidiol Ora...	1 Year - 65 Years	Jazz Pharmaceuticals

Spots Global Cancer Trial Database for tuberous sclerosis complex associated neuropsychiatric disease