Cannabidiol in Children With Refractory Epileptic Encephalopathy: A Phase 1 Open Label Dose Escalation Study (CARE-E)

Who is this study for? Pediatric patients aged 1-10 with refractory epileptic encephalopathy
What treatments are being studied? CanniMed® 1:20
Status: Unknown
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal Extract in a small group of children with refractory epileptic encephalopathy. The dosage of Cannabis Herbal Extract will be gradually increased over a four month time period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 10
Healthy Volunteers: f
View:

• Age 1-10 years

• Epileptic Encephalopathy

• A minimum of at least 1 major seizure per week or 4 major seizures per month. For the purposes of this research study, a major seizure would include atonic, tonic, clonic, tonic-clonic, major myoclonic, myoclonic astatic seizures and epileptic spasms (including infantile spasms)

• Refractory to anticonvulsant medication as per the International League Against Epilepsy (ILAE) Definition of failing 2 appropriate anticonvulsants at therapeutic doses

• The ability to attend appointments regularly

• Negative pregnancy test at screening for females who have reached menarche

Locations
Other Locations
Canada
Universite de Montreal
Montreal
University of Saskatchewan
Saskatoon
University of British Columbia
Vancouver
University of Manitoba
Winnipeg
Time Frame
Start Date: 2017-04-26
Completion Date: 2023-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Medical Cannabis Oil
CanniMed® 1:20
Related Therapeutic Areas
Sponsors
Leads: University of Saskatchewan

This content was sourced from clinicaltrials.gov