Epilepsy, Unspecified, Refractory (Medically) Clinical Trial
Official title:
The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy
| Verified date | January 2020 |
| Source | University of Colorado, Denver |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 150 |
| Est. completion date | November 2020 |
| Est. primary completion date | October 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Month to 20 Years |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Hospital Colorado | Aurora | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| University of Colorado, Denver | Colorado Department of Public Health and Environment |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |