The Pharmacokinetics of Cannabidiol (CBD) and Its Effects in Children With Severe Epilepsy

Dravet Syndrome Clinical Trial

Official title:

The Pharmacokinetics of Cannabidiol (CBD) and Its Effects in Children With Severe Epilepsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02910297
• Other study ID #: CBD-PK-1
• Status: Withdrawn
• Start date: September 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: December 2021
• Source: Gillette Children's Specialty Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if cannabidiol (CBD) obtained via the state of Minnesota reduces seizures in patients with severe intractable epilepsy (Dravet Syndrome or Lennox Gastaut Syndrome), and to measure blood levels of CBD to help determine CBD concentration-response characteristics.

Description:

Patients with medically refractory epilepsy who are registering to take CBD in the State of Minnesota will be offered the opportunity to participate in this study. If consent to participation is obtained, the patient (or more likely, the patient's guardian) will be asked to begin a seizure diary for at least a 7-day period prior (ideally, longer) to receiving the CBD, and to continue tracking seizures throughout the study. Upon receipt of CBD from the Minnesota dispensary, subjects will take their CBD as directed and will return to the clinic for a repeat visit (which is part of standard care) occurring 2-8 weeks after continual use of CBD. During these clinic visits, patients undergo blood draws to monitor their other prescribed AED concentrations as part of standard of care. In addition to the standard blood draw, the research participant will be asked to provide a blood sample of 5 ml to measure CBD concentrations. As most patients are instructed to take CBD two hours prior to their standard of care AEDs, clinical experience indicates that most patients are taking CBD quite early in the morning (around 6 AM). Thus, the time of sample collection will be recorded as hours post-dose, and will likely be nearer peak serum concentrations. If a study participant has an indwelling intravenous access port, they will be asked to provide an additional sample of 5 ml at least one hour after the initial sample. During the repeat visit, subjects will be asked to continue documenting seizure activity in their seizure diary while they continue their CBD treatment. Any changes to AEDs administered concurrently with CBD will also be recorded.

Subjects who are already on a stable regimen of CBD will also be eligible to participate. At a clinic visit, they will be asked to provide a blood sample of 5 ml, the time of each sample will be recorded as hours post-dose of CBD. They will also be asked to begin a seizure diary and continue tracking seizure activity. If a patient terminates their CBD treatment, they will be asked to continue tracking seizure activity after their last CBD dose until their follow-up clinic visit, to determine change in seizure activity while on and off CBD.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 30 Years

Eligibility

Inclusion Criteria:

• Diagnosed with Dravet Syndrome or Lennox-Gastaut Syndrome

• Patients who are planning to obtain medical cannabidiol

• Patients who are already taking medical cannabidiol and are planning to stop taking it.

Exclusion Criteria:

• Patients without a diagnosis of Dravet syndrome or Lennox-Gastaut syndrome

Related Conditions & MeSH terms

• Dravet Syndrome
• Epilepsies, Myoclonic
• Epilepsy
• Lennox Gastaut Syndrome
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gillette Children's Specialty Healthcare	University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in seizures	Subjects or parents/guardians of subjects will record seizure activity in seizure diaries both prior to and during cannabidiol administration	a 7-day seizure diary completed at least twice within 3 months
Secondary	Cannabidiol concentration	Each subject will provide a blood sample of 5 ml to measure concentrations of cannabidiol	1 time at a clinic visit within three months. If a patient has a port, they will be asked to provide an additional blood sample of 5 ml at least one hour after the first sample during the same clinic visit.