Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jazz Pharmaceuticals
Age
1–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant has a well-documented clinical history of epilepsy.
Participant has a clinical diagnosis of Tuberous Sclerosis Complex (TSC) according to the criteria agreed by the 2012 International TSC Consensus Conference.
All medications or interventions for epilepsy (including ketogenic diet and any neurostimulation devices for epilepsy) must have been stable for 1 month prior to screening and the participant is willing to maintain a stable regimen throughout the trial.
You may not be if
Participant has a history of pseudo-seizures.
Participant has clinically significant unstable medical conditions other than epilepsy.
Participant has an illness in the 4 weeks prior to screening or randomization, other than epilepsy, which in the opinion of the investigator could affect seizure frequency.
Participant has undergone general anesthetic in the 4 weeks prior to screening or randomization.
Participant has undergone surgery for epilepsy in the 6 months prior to screening.
Participant is being considered for epilepsy surgery or any procedure involving general anesthesia.
Participant has been taking felbamate for less than 1 year prior to screening.
Participant is taking an oral mTOR inhibitor.
Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP), such as sesame oil.
Participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month or at screening.
Participant is currently using or has in the past used recreational or medicinal cannabis, or cannabinoid-based medications, within the 3 months prior to screening and is unwilling to abstain for the duration for the study.
Participant has tumor growth which, in the opinion of the Investigator, could affect the primary endpoint.
Participant has significantly impaired hepatic function at the screening or randomization visit
Participant has received an IMP within the 12 weeks prior to the screening visit.
Clareo Health | A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
