Epilepsy, Unspecified, Refractory (Medically)NCT02523183
The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy
An observational study of Epilepsy, Unspecified, Refractory (Medically), run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 20 years
- Conditions the study is for
- Epilepsy, Unspecified, Refractory (Medically)
- What is being tested?
- Medical Cannabis
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Being tested
- Medical Cannabis
- Keywords
- Epilepsy, Marijuana
- Medical subject headings
- Epilepsy, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical CannabisDrug
Also called medicinal cannabinoids (MCBD)
Pediatric patients with medically refractory epilepsy and treated with medicinal cannabis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Medical Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Unspecified, Refractory (Medically)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Department of Public Health and Environment
- Responsible party
- Sponsor
- Investigators
- Kelly Knupp, MD, Principal investigator, Assistant Professor of Pediatrics and Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523183
- Sponsor's protocol ID
- 14-1606
- Status last verified
- Jan 2020
- First submitted
- 23 Jul 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT02523183
- Acronym / sponsor ID
- 14-1606
- Keywords
- Epilepsy, Marijuana
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado Department of Public Health and Environment
- Study start
- Jul 2015
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with medically refractory epilepsy | – | Drug: Medical CannabisPediatric 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. |
Who may qualify
- Ages
- 1 month to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (13 listed)
- 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:
- Baseline seizure frequency of at least 2 per week of the any of the following types:
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical CannabisAlso: medicinal cannabinoids (MCBD)Pediatric patients with medically refractory epilepsy and treated with medicinal cannabis. | Drug | Subjects with medically refractory epilepsy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Knupp, MD principal investigator
Assistant Professor of Pediatrics and Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, Unspecified, Refractory (Medically), run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in background and architecture of seizures confirmed by non-investigational EEG (time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.