Full-spectrum Medical Cannabis for Treatment of Spasticity in Patients With Severe Forms of Cerebral Palsy

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study is a double-blind, placebo-controlled, cross over study on 60 children aged 5 to 25 years with severe spasticity related to cerebral palsy (CP), level IV and V with full-spectrum medical cannabis product of CBD/THC ratio 10:1.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Collaborators: PharmaHemp; University of Ljubljana, Faculty of Medicine

Criteria

Inclusion criteria:

• With confirmed diagnosis of cerebral palsy (CP) and classified according to the Gross Motor Function Classification System (GMFCS) as level IV or V

• With spastic unilateral or spastic bilateral type of CP

• Those children/young adults whose parents/caregivers were informed about the aims of the study and have signed the Informed consent form

Exclusion criteria:

• Other proven diseases/conditions with the prevalence of spastic type of muscle tone (e.g. neurodegenerative, metabolic, etc.), and children with liver disease

• Other forms of CP (dyskinetic, ataxic)

• History of psychiatric illness/condition in the family