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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-04-27

No results posted yet for this study

Summary

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.

Conditions

  • Tuberous Sclerosis Complex Associated Neuropsychiatric Disease

Interventions

DRUG

Cannabidiol Oral Solution [Epidiolex]

100 mg/ml Cannabidiol Oral solution

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-29
Primary Completion
2026-04-06
Completion
2026-04-06
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05864846 on ClinicalTrials.gov