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

CBC and differential counts, blood electrolytes, magnesium, calcium, phosphorus, urea \& creatinine, liver enzymes (AST, ALT, gGT)

Electrocardiogram

Determination of levels of cannabidiol (CBD) and delta-9-tetrahydrocannbinol (THC) for determination of levels at following time(s) after ingestion: 0, 1, 2, 4, 8 and 24 hours.

Active substance

Placebo

"A trained physiotherapist will assess spasticity level according to modified Ashworth scale (Bohannon), which is 6-level scale for assessment of spasticity.~Modified Ashworth/Bohannon Scoring Scale (Bohannon and Smith, 1987):~0 No increase in muscle tone~1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM )~2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved~3. Considerable increase in muscle tone, passive movement difficult~4. Affected part(s) rigid in flexion or extension~Best score is 0 (no spasticity), worst score is 4 (severe spasticity)."

"A trained physiotherapist will assess Gross Motor Function Measure (GMFM-88) which is commonly used in the evaluation of gross motor function in children with cerebral palsy~The Gross Motor Function Measure-88 (GMFM-88) is a standardized observational instrument developed to measure change in gross motor function over time. The test consists of 88 items categorized in five dimensions (Dimension A: lying and rolling, Dimension B: sitting, Dimension C: crawling and kneeling, Dimension D: standing and Dimension E: walking, running and jumping). The test was conducted as described in the GMFM-88 manual . A percentage score as compared to maximum is calculated for each dimension and for the total score of the five dimensions.~Reference curves exist for GMFM-88 for each age group.~Floor score is 4 (minimum score / worst), ceiling score (maximum score / best) is 75."

Borg rating of perceived exertion scale

Edmonton symptom assessment system and general impression scale (1 - very much improved; 7 - very much worse).