Treatment of Drug Resistant Epilepsy
| Status: | No longer available |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 2 - 16 |
| Updated: | 1/23/2019 |
Physician Expanded Access to Investigational New Drug Cannabidiol for the Treatment of Drug Resistant Epilepsy
The main goal of this study is to provide treatment with cannabidiol (CBD) to children with
drug resistant epilepsy through a Physician Expanded Access Investigation New Drug protocol.
As the controlled therapeutic use of CBD in children is novel, the primary objective of this
study is to evaluate the safety and efficacy of CBD when administered as adjunctive therapy
in children that have exhausted the majority of FDA approved antiepileptic drug treatment
options.
drug resistant epilepsy through a Physician Expanded Access Investigation New Drug protocol.
As the controlled therapeutic use of CBD in children is novel, the primary objective of this
study is to evaluate the safety and efficacy of CBD when administered as adjunctive therapy
in children that have exhausted the majority of FDA approved antiepileptic drug treatment
options.
Fifty, (50) children will be provided CBD as part of the Principal Investigator's Physician
Expanded Access IND. CBD will be administered as an adjunct to all current antiepileptic
drugs. After the screening visit, a 4 week baseline period will be followed and seizures will
be recorded in the seizure diary given to the patient at this time. The patients will be
clinically evaluated at baseline, once a month for three months and once every three months
thereafter. For the first week after study initiation, patients will be called at day 3 to
review any changes in condition and again at day 7 to review any changes in condition and to
determine whether an increase in dosing is required. Subsequently, patients will be called
each week during the titration period to review any changes in condition and determine
whether an increase in dosing is required. Maximal dose titration should be achieved in most
patients within 5 weeks. In order to ensure safe use at higher doses, patients who receive
more than 600 mg of daily CBD will be evaluated at least monthly until they achieve steady
state at their final fixed maintenance dose. The investigator will be available by telephone
or email throughout the initial four months of the study in between the visits.
Expanded Access IND. CBD will be administered as an adjunct to all current antiepileptic
drugs. After the screening visit, a 4 week baseline period will be followed and seizures will
be recorded in the seizure diary given to the patient at this time. The patients will be
clinically evaluated at baseline, once a month for three months and once every three months
thereafter. For the first week after study initiation, patients will be called at day 3 to
review any changes in condition and again at day 7 to review any changes in condition and to
determine whether an increase in dosing is required. Subsequently, patients will be called
each week during the titration period to review any changes in condition and determine
whether an increase in dosing is required. Maximal dose titration should be achieved in most
patients within 5 weeks. In order to ensure safe use at higher doses, patients who receive
more than 600 mg of daily CBD will be evaluated at least monthly until they achieve steady
state at their final fixed maintenance dose. The investigator will be available by telephone
or email throughout the initial four months of the study in between the visits.
Inclusion Criteria:
- history of a trial of at least four drugs, including one trial of a combination of two
concomitant drugs, without successful seizure control.
- Vagal nerve stimulation: VNS must be on stable settings for a minimum of 1 month,
- RNS deep brain stimulation, or
- the ketogenic diet can be considered equivalent to a drug trial and must be on a
stable ratio for a minimum of 3 months.
- anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment.
- 4 clinically countable seizures per month: Seizure history to include a documented
history of generalized seizures (drop attacks, atonic, tonic-clonic and/or myoclonic),
focal seizures without loss of consciousness with a motor component, focal seizures
with loss of consciousness, or focal seizures with secondary generalization,
Exclusion Criteria:
- Use of CBD based product within the previous 30 days.
- Initiation of felbamate within 6 months.
- Allergy to CBD or any cannabinoid.
- Unable to comply with study visits/requirements.
- Diagnosis of Dravet Syndrome or Lennox-Gastaut syndrome will be excluded completely
from this trial.
- Cannabidiol is contraindicated in pregnancy. Female subjects who are pregnant will be
excluded from the study. If a female subject is able to become pregnant, she will be
given a serum pregnancy test before entry into the study. Female subjects will be
informed not become pregnant while taking cannabidiol. Female subjects must tell the
investigator and consult an obstetrician or maternal-fetal specialist if they become
pregnant during the study.
We found this trial at
2
sites
Miami, Florida 33155
Principal Investigator: Ian Miller, M.D.
Phone: 305-662-8330
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