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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02523183|
Recruitment Status : Recruiting
First Posted : August 14, 2015
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment|
|Epilepsy, Unspecified, Refractory (Medically)||Drug: Medical Cannabis|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||November 2019|
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
Pediatric patients with medically refractory epilepsy and treated with medicinal cannabis.
Other Name: medicinal cannabinoids (MCBD)
- 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523183
|Contact: Nanastasia Welnick||720-777-8608||seizuresCBDresearch@childrenscolorado.org|
|Contact: Carl Zimmerman||720-777-8008||seizuresCBDresearch@childrenscolorado.org|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Nanastasia Welnick 720-777-8608 seizuresCBDresearch@childrenscolorado.org|
|Contact: Carl Zimmerman 720-777-8008 seizuresCBDresearch@childrenscolorado.org|
|Principal Investigator: Kelly Knupp, MD|
|Sub-Investigator: Kevin Chapman, MD|
|Principal Investigator:||Kelly Knupp, MD||Assistant Professor of Pediatrics and Neurology|