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Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy (CBD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02660255
Expanded Access Status : Approved for marketing
First Posted : January 21, 2016
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
GW Pharmaceuticals Ltd.
Information provided by (Responsible Party):
Christopher J. Kratochvil, M.D., University of Nebraska

Tracking Information
First Submitted Date December 21, 2015
First Posted Date January 21, 2016
Last Update Posted Date May 30, 2019
 
Descriptive Information
Brief Title Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy
Brief Summary This is an observational, open-label, flexible dose study that will prospectively and longitudinally assess the effect of Cannabidiol (CBD) therapy in patients with drug-resistant epilepsies through a Physician Expanded Access Investigational New Drug protocol.
Detailed Description

This study will test if Cannabidiol (CBD) therapy is safe in humans and reduces the number and/or severity of seizures in patients with drug resistant epilepsy when taken in addition to current anti-epileptic drugs (AEDs).

To be eligible, subjects must:

  • have drug-resistant epilepsy
  • be between 1 and 60 years of age

Subjects may participate for up to 2 years and may continue to receive the drug as available, until the compassionate use is terminated or the drug becomes approved by the FDA.

The study includes:

  • Baseline, Screening and 2 phone calls
  • 12 week drug titration (6 visits) and 5 phone calls
  • Approximately 1 year and 9 month Treatment period (7 visits)

Subjects will come in for visits approximately every two weeks for the first three months and then quarterly for the remainder of the study. Subjects' antiepileptic drug levels will be tested to monitor for drug interactions. Lab assessments (CBC, CMP, urinalysis) will be performed to monitor for changes in bone marrow, liver, and kidney function to ensure safe use.

Cannabidiol will be in the form of 100 mg/ml oral solution. Subjects will be given CBD to take in addition to their current anti-epileptic drug (AED) regimen.

Study Type Expanded Access
Intervention Drug: Cannabidiol
Formulation: 100mg/ml CBD (Epidiolex) Solution
Other Name: Epidiolex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02660255
Responsible Party Christopher J. Kratochvil, M.D., University of Nebraska
Study Sponsor Christopher J. Kratochvil, M.D.
Collaborators GW Pharmaceuticals Ltd.
Investigators
Principal Investigator: Deepak Madhavan, MD University of Nebraska
PRS Account University of Nebraska
Verification Date May 2019