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

NCT02523183 | Unknown

• 1 other identifier: 14-1606
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy, Unspecified, Refractory (Medically)

Keywords

Epilepsy; Marijuana

Outcome Measures

Primary Outcomes (3)

• Changes from baseline in background and architecture of seizures confirmed by non-investigational EEG

  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.

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Seizure Frequency

  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.

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Pediatric Epilepsy Side Effects Questionnaire

  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.

  Baseline, 4 weeks, 8 weeks, and 12 weeks

Study Arms (1)

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.

Drug: Medical Cannabis

Interventions

Medical Cannabis DRUG

Pediatric patients with medically refractory epilepsy and treated with medicinal cannabis.

Also known as: medicinal cannabinoids (MCBD)

Subjects with medically refractory epilepsy

Eligibility Criteria

• Age: 1 Month - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Male or Female \>1 month of age
• 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
• 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
• baseline anti-seizure medications at stable doses for a minimum of 4 weeks prior to enrollment.
• Written informed consent obtained from the patient or the patient's legal representative.

You may not qualify if:

• Epilepsies associated with rapidly progressing neurodegenerative diseases ex: Rasmussen encephalitis, and tumors.
• Epilepsies associated with treatable inborn errors of metabolism
• 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.
• Non-epileptic events.
• Current use of MCBD products (Note: Patient is eligible if currently using MCBD but will be switching to a different product).

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado Department of Public Health and Environment: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Links

• More information about medical marijuana research at childrens hospital colorado

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples will be collected

MeSH Terms

Conditions

Epilepsy; Marijuana Abuse

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Kelly Knupp, MD

  Assistant Professor of Pediatrics and Neurology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: August 14, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)