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The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy

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: NCT02523183
Recruitment Status : Active, not recruiting
First Posted : August 14, 2015
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Colorado Department of Public Health and Environment
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date July 23, 2015
First Posted Date August 14, 2015
Last Update Posted Date January 18, 2020
Study Start Date July 2015
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2018)
  • Changes from baseline in background and architecture of seizures confirmed by non-investigational EEG [ Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks ]
    Prolonged EEG recordings lasting 24-48 hours (whichever is clinically indicated) will be performed in either the home setting as an ambulatory EEG or in the hospital in the Epilepsy Monitoring Unit. This decision will be made on a clinical basis. This will allow for objective quantification of seizures in children with frequent seizures that occur on a daily basis and background EEG changes for other children. Two EEGs will be done: one at baseline, and one at the end of the study.
  • Seizure Frequency [ Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks ]
    Each subject will maintain a seizure diary. Rescue drug use and VNS (Vagus Nerve Stimulation) activations will be tracked as an adjunct to all current anti-seizure medications. Frequency of status epilepticus will be tracked as well as hospital visits for seizures or adverse events from MCBD. Clinical evaluations will be taken every 2 months throughout the duration of the study. Subjects will be monitored every 2 weeks by telephone and/or email.
  • Pediatric Epilepsy Side Effects Questionnaire [ Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks ]
    Side effects will be evaluated using PESQ (Pediatric epilepsy Side Effects Questionnaire). This questionnaire will be administered 4 weeks, 8 weeks, and 12 weeks after baseline.
Original Primary Outcome Measures
 (submitted: August 11, 2015)
  • Changes from baseline in background and architecture of seizures confirmed by non-investigational EEG [ Time Frame: 4 months ]
    Prolonged EEG recordings lasting 24-48 hours (whichever is clinically indicated) will be performed in either the home setting as an ambulatory EEG or in the hospital in the Epilepsy Monitoring Unit. This decision will be made on a clinical basis. This will allow for objective quantification of seizures in children with frequent seizures that occur on a daily basis and background EEG changes for other children. Two EEGs will be done: one at baseline, and one at the end of the study.
  • Seizure Frequency [ Time Frame: Biweekly for four months ]
    Each subject will maintain a seizure diary. Rescue drug use and VNS (Vagus Nerve Stimulation) activations will be tracked as an adjunct to all current anti-seizure medications. Frequency of status epilepticus will be tracked as well as hospital visits for seizures or adverse events from MCBD. Clinical evaluations will be taken every 2 months throughout the duration of the study. Subjects will be monitored every 2 weeks by telephone and/or email.
  • Pediatric Epilepsy Side Effects Questionnaire [ Time Frame: 3 months ]
    Side effects will be evaluated using PESQ (Pediatric epilepsy Side Effects Questionnaire). This questionnaire will be administered 4 weeks, 8 weeks, and 12 weeks after baseline.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy
Official Title The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy
Brief Summary Many families of children with medically refractory epilepsy are choosing to use medicinal cannabinoids (MCBD) as an adjunctive alternative treatment option. The safety, tolerability and efficacy of these products are not known. The primary objective of this study is to determine how the use of MCBD affects children with medically refractory epilepsy in an observational study. Measures of evaluation to be used will include: laboratory values, developmental measures, seizure diaries and serial electroencephalographic (EEG) recordings.
Detailed Description This is an observational study of a family's choice to use MCBD and the effect of this substance on medically refractory epilepsy in children. The risks associated with this use are not well known. There have recently been reports of stroke, liver dysfunction and altered anticonvulsant levels. In addition, there have been long term risks reported of decreased memory function, cognitive problems and executive function abnormalities. This study does not condone or advocate the use of the substance but merely seeks to document the short term effects of the use in this population. It should be noted that providers at Children's Hospital Colorado are not registered providers for medicinal cannabis; therefore, this will be an observational study of effects of this substance as prescribed by other physicians outside of our institution.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood samples will be collected
Sampling Method Non-Probability Sample
Study Population Pediatric epilepsy patients who are followed at Children's Hospital Colorado with medically refractory epilepsy, and whom the family has decided to treat with medicinal cannabis. Children who have not been treated with medically accepted standard treatment for their epilepsy condition will not be accepted into this study as the researchers do not want to be misperceived as condoning the use of medical marijuana in lieu of standard treatment.
Condition Epilepsy, Unspecified, Refractory (Medically)
Intervention Drug: Medical Cannabis
Pediatric patients with medically refractory epilepsy and treated with medicinal cannabis.
Other Name: medicinal cannabinoids (MCBD)
Study Groups/Cohorts Subjects with medically refractory epilepsy
Pediatric epilepsy patients who are followed at Children's Hospital Colorado with medically refractory epilepsy, and whom the family has decided to treat with medical cannabis.
Intervention: Drug: Medical Cannabis
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
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 11, 2015)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Male or Female >1 month of age
  2. Documentation of a diagnosis of medically refractory epilepsy as evidenced by medical records, genetic testing and/or the following clinical features:

    • Failure to control seizures despite an appropriate trial of two anticonvulsant medications at therapeutic doses
  3. Baseline seizure frequency of at least 2 per week of the any of the following types:

    • Generalized tonic-clonic
    • Clonic
    • Tonic
    • Hemiconvulsive
    • Drop attacks
    • Focal motor
    • Epileptic spasms
  4. 1-3 baseline anti-seizure medications at stable doses for a minimum of 4 weeks prior to enrollment.
  5. Written informed consent obtained from the patient or the patient's legal representative.

Exclusion Criteria:

  1. Epilepsies associated with rapidly progressing neurodegenerative diseases ex: Rasmussen encephalitis, and tumors.
  2. Epilepsies associated with treatable inborn errors of metabolism
  3. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  4. Non-epileptic events.
  5. Current use of MCBD products (Note: Patient is eligible if currently using MCBD but will be switching to a different product).
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 20 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02523183
Other Study ID Numbers 14-1606
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Colorado Department of Public Health and Environment
Investigators
Principal Investigator: Kelly Knupp, MD Assistant Professor of Pediatrics and Neurology
PRS Account University of Colorado, Denver
Verification Date January 2020