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

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.

Conditions

• Children, Adult
• Spastic Cerebral Palsy
• Quality of Life
• Cannabis
• Physical Disability

Interventions

DIAGNOSTIC_TEST

Cannabinoid Levels

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.

DRUG

Full-spectrum Medical Canabis Product (HemPhar)

Active substance

DRUG

Placebo

Placebo

DIAGNOSTIC_TEST

Lab tests

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

DIAGNOSTIC_TEST

ECG

Electrocardiogram

DIAGNOSTIC_TEST

Spasticity level according to modified Ashworth scale (Bohannon)

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).

DIAGNOSTIC_TEST

Gross Motor Function Measure

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.

DIAGNOSTIC_TEST

Borg rating of perceived exertion scale

Borg rating of perceived exertion scale

DIAGNOSTIC_TEST

Edmonton symptom assessment system

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

Sponsors & Collaborators

• PharmaHemp

  collaborator UNKNOWN

• University of Ljubljana, Faculty of Medicine

  collaborator OTHER

• University Medical Centre Ljubljana

  lead OTHER

Principal Investigators

• Damjan Osredkar, MD, PhD · UMC Ljubljana

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

5 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-15

Primary Completion

2023-12-01

Completion

2024-02-29

Countries

• Slovenia

Study Locations