Children, AdultHemPharNCT04634136
Full-spectrum Medical Cannabis for Treatment of Spasticity in Patients With Severe Forms of Cerebral Palsy
A study testing Lab tests, ECG and Cannabinoid Levels in people with Children, Adult and Spastic Cerebral Palsy, run by University Medical Centre Ljubljana at 2 sites in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Children, Adult, Spastic Cerebral Palsy, Quality of Life
- What is being tested?
- Lab tests, ECG and Cannabinoid Levels
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesSlovenia
- Study dates
- 15 Oct 2020to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites
PharmaHemp
Ljubljana, 1000
University Medical Centre Ljubljana
Ljubljana
About this study
Official 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
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.
Read the detailed description
Test components:
- Active: Full-spectrum medical cannabis with ratio of CBD:THC 10:1 (HemPhar)
- Placebo (both of the same producer)
Study Steps
- Informed consent should be signed by parents/caregivers.
- Weight of the participant should be determined and an IV line inserted. The following lab tests should be performed: CBC and differential counts, blood electrolytes, magnesium, calcium, phosphorus, urea \& creatinine, liver enzymes (AST, ALT, gGT)
- ECG performed and analyzed
- A trained physiotherapist will perform the following motor assessments: spasticity level according to modified Ashworth scale (Bohannon), function/activity assessment with the use of Gross Motor Function Measure scale (GMFM-88) and assessment of muscle power with dynamometer.
- Randomization of patients into one of the two arms of the study
- Active substance or placebo are introduced thereafter (as an oral oily solution for oral application) in a starting dose of 0.08 mg/kg body weight (BWt)/day divided in 2 doses (the dose is according to the THC content). The dose is gradually increased, every 3 days for 0.08 mg THC/ kg BWt/day, until the maximum dose of 1 mg THC/kg BWt/day is reached, or else until adverse effects are noted. It is expected that the average dose will be 0.33 mg/kg BWt per day.
- The parents/caregivers are given questionnaires/scales and also given oral instructions on how to fulfil them (Edmonton scale, Borg scale and Global Impression of Change - GIC) and the paper to take down notes on possible side/adverse effects while taking the preparation (either active substance or placebo).
- After 6 weeks of taking the substance or at the premature end of the study again the lab tests will be performed as well as the motor assessment by the physiotherapist (as above at inclusion).
- In patients, who have been receiving placebo for the first 6 weeks, the active substance is given for the next 6 weeks, as described above (under 6). The patients who have been receiving the active substance for the first 6 weeks will continue to do so for the next 6 weeks.
- Additional blood samples are taken at 6 weeks in both groups for analysis of levels of cannabidiol (CBD) as well as delta-9-tetrahydrocannbinol (THC) - around 4 ml of blood for determination of both levels at time(s) after ingestion: 0, 1, 2, 4, 8 and 24 hours.
- At the end of the study (after 12 weeks) again repeat:
- CBC and differential counts, blood electrolytes, magnesium, calcium, phosphorus, urea \& creatinine, liver enzymes (AST, ALT, gGT)
- ECG
- Motor assessments by a physiotherapist (Ashworth/Bohannon, GMFM 88, dynamometer)
- Pharmacokinetics: 4 ml of blood for determination of phamacokinetics after ingestion of the last dose (as in point 10 above)
- Evaluation of the questionnaires
NOTE: if severe side/adverse effects are noted, the test compound should be stopped immediately. If mild/moderate side/adverse effects are noted, the test component should be gradually stopped: for 0,08 mg/kg BWt/day, every 3 days.
- Being tested
- Lab tests, ECG, Cannabinoid Levels, Full-spectrum Medical Canabis Product (HemPhar), Placebo
- Keywords
- cerebral palsy, severe spasticity, child, cannabis treatment, quality of life, young adult
- Medical subject headings
- Cerebral Palsy, Marijuana Abuse, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lab testsDiagnostic test
Also called Basic hematology and biochemistry
CBC and differential counts, blood electrolytes, magnesium, calcium, phosphorus, urea \& creatinine, liver enzymes (AST, ALT, gGT)
ECGDiagnostic test
Electrocardiogram
Cannabinoid LevelsDiagnostic test
Also called Pharmacokinetics of cannabinoids
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.
Full-spectrum Medical Canabis Product (HemPhar)Drug
Also called Active substance
Active substance
PlaceboDrug
Placebo
Spasticity level according to modified Ashworth scale (Bohannon)Diagnostic test
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).
Gross Motor Function MeasureDiagnostic test
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 scaleDiagnostic test
Borg rating of perceived exertion scale
Edmonton symptom assessment systemDiagnostic test
Edmonton symptom assessment system and general impression scale (1 - very much improved; 7 - very much worse).
| Study group | Role | What they receive |
|---|---|---|
| Active Substance: Full-spectrum Medical Canabis Product (HemPhar) | Active comparator | For research purposes the investigators will use a preparation in the form of drops, containing full-spectrum medical cannabis extract (HemPhar) with THC:CBD ratio 1:10, and other cannabinoids as well, provided by Pharmahemp, GMP-certified medical cannabis producer. Receives: Diagnostic Test: Lab tests; Diagnostic Test: ECG; Diagnostic Test: Cannabinoid Levels; Drug: Full-spectrum Medical Canabis Product (HemPhar); Diagnostic Test: Spasticity level according to modified Ashworth scale (Bohannon); Diagnostic Test: Gross Motor Function Measure; Diagnostic Test: Borg rating of perceived exertion scale; Diagnostic Test: Edmonton symptom assessment system |
| Placebo | Placebo comparator | For research purposes the investigators will use a placebo in the form of drops, containing oil only, provided by Pharmahemp, GMP-certified medical cannabis producer. Receives: Diagnostic Test: Lab tests; Diagnostic Test: ECG; Drug: Placebo; Diagnostic Test: Spasticity level according to modified Ashworth scale (Bohannon); Diagnostic Test: Gross Motor Function Measure; Diagnostic Test: Borg rating of perceived exertion scale; Diagnostic Test: Edmonton symptom assessment system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
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.
Measured: 6 weeks
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).
Measured: 12 weeks
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.
Measured: 12 weeks
Safety and tolerability of FSMC
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start15 Oct 2020
- Primary completion1 Dec 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children, AdultStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Active substance: Full-spectrum medical cannabis product of CBD/THC ratio 10:1. Arm 1: Active substance. The starting dose will be 0,08 mg THC per kilo body weight daily in 2 divided doses which will gradually be increased (escalating dose of 0,08 mg THC kg/d) until maximal dose of 1 mg/kg/d. Arm 2: Placebo Crossover: After 6 weeks Arm 2 will also receive the active substance and patients in both arms will continue receiving the active substance for the next 6 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaHemp, University of Ljubljana, Faculty of Medicine
- Responsible party
- Principal investigator, Damjan Osredkar, University Medical Centre Ljubljana
- Investigators
- Damjan Osredkar, MD, PhD, Study director, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634136
- Sponsor's protocol ID
- 0120-162/2017/8
- Acronym
- HemPhar
- Status last verified
- May 2023
- First submitted
- 4 Nov 2020
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04634136
- Acronym / sponsor ID
- HemPhar / 0120-162/2017/8
- Keywords
- cerebral palsy, severe spasticity, child, cannabis treatment, quality of life, young adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- PharmaHemp, University of Ljubljana, Faculty of Medicine
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Test components:
- Active: Full-spectrum medical cannabis with ratio of CBD:THC 10:1 (HemPhar)
- Placebo (both of the same producer)
Study Steps
- Informed consent should be signed by parents/caregivers.
- Weight of the participant should be determined and an IV line inserted. The following lab tests should be performed: CBC and differential counts, blood electrolytes, magnesium, calcium, phosphorus, urea \& creatinine, liver enzymes (AST, ALT, gGT)
- ECG performed and analyzed
- A trained physiotherapist will perform the following motor assessments: spasticity level according to modified Ashworth scale (Bohannon), function/activity assessment with the use of Gross Motor Function Measure scale (GMFM-88) and assessment of muscle power with dynamometer.
- Randomization of patients into one of the two arms of the study
- Active substance or placebo are introduced thereafter (as an oral oily solution for oral application) in a starting dose of 0.08 mg/kg body weight (BWt)/day divided in 2 doses (the dose is according to the THC content). The dose is gradually increased, every 3 days for 0.08 mg THC/ kg BWt/day, until the maximum dose of 1 mg THC/kg BWt/day is reached, or else until adverse effects are noted. It is expected that the average dose will be 0.33 mg/kg BWt per day.
- The parents/caregivers are given questionnaires/scales and also given oral instructions on how to fulfil them (Edmonton scale, Borg scale and Global Impression of Change - GIC) and the paper to take down notes on possible side/adverse effects while taking the preparation (either active substance or placebo).
- After 6 weeks of taking the substance or at the premature end of the study again the lab tests will be performed as well as the motor assessment by the physiotherapist (as above at inclusion).
- In patients, who have been receiving placebo for the first 6 weeks, the active substance is given for the next 6 weeks, as described above (under 6). The patients who have been receiving the active substance for the first 6 weeks will continue to do so for the next 6 weeks.
- Additional blood samples are taken at 6 weeks in both groups for analysis of levels of cannabidiol (CBD) as well as delta-9-tetrahydrocannbinol (THC) - around 4 ml of blood for determination of both levels at time(s) after ingestion: 0, 1, 2, 4, 8 and 24 hours.
- At the end of the study (after 12 weeks) again repeat:
- CBC and differential counts, blood electrolytes, magnesium, calcium, phosphorus, urea \& creatinine, liver enzymes (AST, ALT, gGT)
- ECG
- Motor assessments by a physiotherapist (Ashworth/Bohannon, GMFM 88, dynamometer)
- Pharmacokinetics: 4 ml of blood for determination of phamacokinetics after ingestion of the last dose (as in point 10 above)
- Evaluation of the questionnaires
NOTE: if severe side/adverse effects are noted, the test compound should be stopped immediately. If mild/moderate side/adverse effects are noted, the test component should be gradually stopped: for 0,08 mg/kg BWt/day, every 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Active substance: Full-spectrum medical cannabis product of CBD/THC ratio 10:1. Arm 1: Active substance. The starting dose will be 0,08 mg THC per kilo body weight daily in 2 divided doses which will gradually be increased (escalating dose of 0,08 mg THC kg/d) until maximal dose of 1 mg/kg/d. Arm 2: Placebo Crossover: After 6 weeks Arm 2 will also receive the active substance and patients in both arms will continue receiving the active substance for the next 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Active Substance: Full-spectrum Medical Canabis Product (HemPhar) | Active comparator | Diagnostic Test: Lab tests, Diagnostic Test: ECG, Diagnostic Test: Cannabinoid Levels, Drug: Full-spectrum Medical Canabis Product (HemPhar), Diagnostic Test: Spasticity level according to modified Ashworth scale (Bohannon), Diagnostic Test: Gross Motor Function Measure, Diagnostic Test: Borg rating of perceived exertion scale, Diagnostic Test: Edmonton symptom assessment systemFor research purposes the investigators will use a preparation in the form of drops, containing full-spectrum medical cannabis extract (HemPhar) with THC:CBD ratio 1:10, and other cannabinoids as well, provided by Pharmahemp, GMP-certified medical cannabis producer. |
| Placebo | Placebo comparator | Diagnostic Test: Lab tests, Diagnostic Test: ECG, Drug: Placebo, Diagnostic Test: Spasticity level according to modified Ashworth scale (Bohannon), Diagnostic Test: Gross Motor Function Measure, Diagnostic Test: Borg rating of perceived exertion scale, Diagnostic Test: Edmonton symptom assessment systemFor research purposes the investigators will use a placebo in the form of drops, containing oil only, provided by Pharmahemp, GMP-certified medical cannabis producer. |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lab testsAlso: Basic hematology and biochemistryCBC and differential counts, blood electrolytes, magnesium, calcium, phosphorus, urea \& creatinine, liver enzymes (AST, ALT, gGT) | Diagnostic test | Active Substance: Full-spectrum Medical Canabis Product (HemPhar), Placebo |
| ECGElectrocardiogram | Diagnostic test | Active Substance: Full-spectrum Medical Canabis Product (HemPhar), Placebo |
| Cannabinoid LevelsAlso: Pharmacokinetics of cannabinoidsDetermination 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. | Diagnostic test | Active Substance: Full-spectrum Medical Canabis Product (HemPhar) |
| Full-spectrum Medical Canabis Product (HemPhar)Also: Active substanceActive substance | Drug | Active Substance: Full-spectrum Medical Canabis Product (HemPhar) |
| PlaceboPlacebo | Drug | Placebo |
| 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 | Active Substance: Full-spectrum Medical Canabis Product (HemPhar), Placebo |
| Gross Motor Function MeasureA 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 | Active Substance: Full-spectrum Medical Canabis Product (HemPhar), Placebo |
| Borg rating of perceived exertion scaleBorg rating of perceived exertion scale | Diagnostic test | Active Substance: Full-spectrum Medical Canabis Product (HemPhar), Placebo |
| Edmonton symptom assessment systemEdmonton symptom assessment system and general impression scale (1 - very much improved; 7 - very much worse). | Diagnostic test | Active Substance: Full-spectrum Medical Canabis Product (HemPhar), Placebo |
Primary outcome
Effect on spasticity (6w; FSMC vs placebo)
Time frame: 6 weeks
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).
Effect on Gross Motor Function Measure (6w; FSMC vs placebo)
Time frame: 6 weeks
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.
Effect on spasticity (12w; 12w-FSMC vs 6w-FSMC)
Time frame: 12 weeks
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).
Effect on Gross Motor Function Measure (12w; 12w-FSMC vs 6w-FSMC)
Time frame: 12 weeks
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.
Safety and tolerability of FSMC
Time frame: 12 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damjan Osredkar, MD, PhD study director
UMC Ljubljana
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lab tests, ECG and Cannabinoid Levels in people with Children, Adult and Spastic Cerebral Palsy, run by University Medical Centre Ljubljana at 2 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on spasticity (6w; FSMC vs placebo) (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.