- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02523183
The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy
January 14, 2020 updated by: University of Colorado, Denver
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.
Study Overview
Status
Unknown
Intervention / Treatment
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
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 20 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- 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
- 1-3 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Pediatric patients with medically refractory epilepsy and treated with medicinal cannabis.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 4 weeks, 8 weeks, and 12 weeks
|
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.
|
Baseline, 4 weeks, 8 weeks, and 12 weeks
|
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.
|
Baseline, 4 weeks, 8 weeks, and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kelly Knupp, MD, Assistant Professor of Pediatrics and Neurology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Anticipated)
October 1, 2020
Study Completion (Anticipated)
November 1, 2020
Study Registration Dates
First Submitted
July 23, 2015
First Submitted That Met QC Criteria
August 11, 2015
First Posted (Estimate)
August 14, 2015
Study Record Updates
Last Update Posted (Actual)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 14, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-1606
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epilepsy, Unspecified, Refractory (Medically)
-
Madeline FieldsRecruitingDrug Resistant Epilepsy | Refractory Epilepsy | Medically Refractory EpilepsyUnited States
-
Johns Hopkins UniversityVitaflo International, LtdCompletedEpilepsy | Seizure | Catamenial Epilepsy | Medically Resistant Epilepsy | Medically Resistant SeizuresUnited States
-
Johns Hopkins UniversityNutricia LiverpoolCompletedEpilepsy | Seizure | Medically Resistant Epilepsy | Medically Resistant SeizuresUnited States
-
Johns Hopkins UniversityMayo Clinic; NYU Langone Health; Rush University Medical Center; Oregon Health... and other collaboratorsCompletedEpilepsy | Status Epilepticus | Seizure | Refractory Status Epilepticus | Medically Resistant Status EpilepticusUnited States
-
University of ArizonaVirginia Polytechnic Institute and State University; Arizona State UniversityEnrolling by invitationCognition | Medically Intractable EpilepsyUnited States
-
Baptist Health South FloridaFlorida International University; U.S. National Science FoundationTerminatedEpilepsy | Status Epilepticus | Epilepsia Partialis Continua | Epilepsia Partialis Continua, Refractory (Medically)United States
-
University Health Network, TorontoUnknownMedically Intractable EpilepsyCanada
-
NaviFUS CorporationTaipei Veterans General Hospital, TaiwanCompletedDrug Resistant Epilepsy | Epilepsy, Drug Resistant | Intractable Epilepsy | Refractory Epilepsy | Drug Refractory Epilepsy | Epilepsy, Drug Refractory | Epilepsy, Intractable | Medication Resistant EpilepsyTaiwan
-
Seoul National University HospitalUnknownEpilepsy, Unspecified, IntractableKorea, Republic of
-
Boston Scientific CorporationCompletedChronic, Medically Refractory HeadacheUnited States
Clinical Trials on Medical Cannabis
-
HaEmek Medical Center, IsraelTechnion, Israel Institute of Technology; Syqe MedicalNot yet recruitingChemotherapy-induced Peripheral NeuropathyIsrael
-
Florida State UniversityCompleted
-
University of ManitobaCanadian Institutes of Health Research (CIHR); Canadian Cancer Society (CCS); The Canadian Collaborative for Childhood Cannabinoid TherapeuticsRecruitingEpilepsy | Cancer | Neurodevelopmental DisordersCanada
-
Eli Sprecher, MDRecruitingHealthy | Crohn Disease | Ulcerative Colitis | PouchitisIsrael
-
Massachusetts General HospitalCompletedDepression | Pain | Insomnia | AnxietyUnited States
-
M. H MediCane Ltd.RecruitingDementia | Alzheimer Disease | Agitation,Psychomotor | Disruptive BehaviorIsrael
-
University Health Network, TorontoShoppers Drug Mart; integrated medhealth communicationRecruitingDepression | Epilepsy | Pain | Sleep | AnxietyCanada
-
TO PharmaceuticalsWithdrawn
-
Universita degli Studi della BasilicataSan Carlo Public Hospital, Potenza, ItalyCompleted
-
Sheba Medical CenterRecruitingParkinson Disease | Bladder, OveractiveIsrael