Quality of Life Clinical Trial
— HemPharOfficial title:
Full-spectrum Medical Canabis Product (HemPhar) With a CBD:THC Ratio of 10:1 for Treatment of Spasticity in Children and Young Adults With Severe Forms of Cerebral Palsy
Verified date | May 2023 |
Source | University Medical Centre Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | February 29, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 25 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Slovenia | PharmaHemp | Ljubljana | |
Slovenia | University Medical Centre Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana | PharmaHemp, University of Ljubljana, Faculty of Medicine |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect on spasticity (6w; FSMC vs 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 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 ) More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension Best score is 0 (no spasticity), worst score is 4 (severe spasticity). |
6 weeks | |
Primary | Effect on Gross Motor Function Measure (6w; FSMC vs placebo) | 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. |
6 weeks | |
Primary | Effect on spasticity (12w; 12w-FSMC vs 6w-FSMC) | 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 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 ) More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension Best score is 0 (no spasticity), worst score is 4 (severe spasticity). |
12 weeks | |
Primary | Effect on Gross Motor Function Measure (12w; 12w-FSMC vs 6w-FSMC) | 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. |
12 weeks | |
Primary | Safety and tolerability of FSMC | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 12 weeks |
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