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

NCT02910297 | Withdrawn

• 1 other identifier: CBD-PK-1
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dravet Syndrome; Lennox Gastaut Syndrome

Keywords

cannabidiol; Dravet Syndrome; Lennox Gastaut Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cannabidiol concentration

  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.

Eligibility Criteria

• Age: 2 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have registered or plan to register with the state of Minnesota for taking medical cannabis and have severe intractable epilepsy (Dravet Syndrome or Lennox Gastaut Syndrome)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gillette Children's Specialty Healthcare: lead
• University of Minnesota: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples collected to measure cannabidiol concentrations

MeSH Terms

Conditions

Epilepsies, Myoclonic; Lennox Gastaut Syndrome

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Samuel A Roiko, Ph.D.

  Gillette Children's Specialty Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: September 22, 2016
• Study Start: September 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: December 16, 2021

Record last verified: 2021-12