Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms
ConditionParkinson Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorLaboratorio Elea Phoenix S.A.
About this trial
Parkinson disease (PD) is a chronic, progressive neurodegenerative disorder characterized by clinical motor and non-motor symptoms. Knowing the potential benefits has led to the use of cannabis as an alternative therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants between 40 and 80 years old.
Participants diagnosed with PD according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease (72), and to the Brain Bank Criteria for Parkinson's disease, with mild to moderate disease as measured by the modified Hoehn and Yahr scale. (Both clinical criteria are included since many of the study participants were diagnosed with previous criteria and others with current criteria, both of which are very similar and do not change or raise any doubt about the diagnosis of the disease).
Participants who have not changed their anti-Parkinson's drugs (or dose) at least one month prior to study entry.
Acceptance by the participant by signing the ICF.
Disqualifiers
Evidence of dementia, Mini-Mental State Exam score less than 24 or with previous diagnosis by cognitive assessment .
Severe psychiatric pathology: severe depression, treatment-refractory psychosis. Evaluation by psychiatrist who confirms the pathology. History of hospitalization in a psychiatric center or mental health center is an exclusion criterion regardless of the time spent since hospitalization or the reason for which the patient was hospitalized.
Known or suspected allergy to cannabinoids or inactive ingredients used in the formulation of the study drug.
History of drug or alcohol dependence.
Trial design
Design model
Parallel
Treatments tested in this trial
Cannabidiol 100 mg/ml
DrugThe following dose regime for the 4 treatment arms will be used: DOSE TITRATION PERIOD: First 5 days: 0.3 mL/day (1 dose) Subsequent 5 days: 0.6 mL/day (2 doses of 0.3 mL/dose) Subsequent 5 days: 0.8 mL/day (2 doses of 0.4 mL/dose) Last 5 days: 1 mL/day (2 doses of 0.4 mL/dose) PERIOD OF ACTIVE TREATMENT Continue with the last dose set by the titration schedule (for 12 weeks). PERIOD OF TREATMENT INTERRUPTION Medication is gradually discontinued every 7 days until complete termination. The first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.
cannabidiol 300 mg/ml
DrugThe following dose regime for the 4 treatment arms will be used: DOSE TITRATION PERIOD: First 5 days: 0.3 mL/day (1 dose) Subsequent 5 days: 0.6 mL/day (2 doses of 0.3 mL/dose) Subsequent 5 days: 0.8 mL/day (2 doses of 0.4 mL/dose) Last 5 days: 1 mL/day (2 doses of 0.4 mL/dose) PERIOD OF ACTIVE TREATMENT Continue with the last dose set by the titration schedule (for 12 weeks). PERIOD OF TREATMENT INTERRUPTION Medication is gradually discontinued every 7 days until complete termination. The first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.
Cannabidiol 400 mg/ml
DrugThe following dose regime for the 4 treatment arms will be used: DOSE TITRATION PERIOD: First 5 days: 0.3 mL/day (1 dose) Subsequent 5 days: 0.6 mL/day (2 doses of 0.3 mL/dose) Subsequent 5 days: 0.8 mL/day (2 doses of 0.4 mL/dose) Last 5 days: 1 mL/day (2 doses of 0.4 mL/dose) PERIOD OF ACTIVE TREATMENT Continue with the last dose set by the titration schedule (for 12 weeks). PERIOD OF TREATMENT INTERRUPTION Medication is gradually discontinued every 7 days until complete termination. The first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.
Placebo
DrugThe following dose regime for the 4 treatment arms will be used: DOSE TITRATION PERIOD: First 5 days: 0.3 mL/day (1 dose) Subsequent 5 days: 0.6 mL/day (2 doses of 0.3 mL/dose) Subsequent 5 days: 0.8 mL/day (2 doses of 0.4 mL/dose) Last 5 days: 1 mL/day (2 doses of 0.4 mL/dose) PERIOD OF ACTIVE TREATMENT Continue with the last dose set by the titration schedule (for 12 weeks). PERIOD OF TREATMENT INTERRUPTION Medication is gradually discontinued every 7 days until complete termination. The first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.
Treatment groups
88 Participants
are divided into 4 treatment groupsGroup A: Group CBD 100Active comparator 1 intervention
Group B: Group CBD 300Active comparator 1 intervention
Group C: Group CBD 400Active comparator 2 interventions
Group D: Group PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients with advers events related to treatment acording to CTCAE v5.0
Frequency of adverse events by a global comparison of all dose or placebo groups Range: 1 to 5 Higher values represent a worse disease state
Time frame
up to 21 weeksSecondary outcomes
1
Changes in differents motors scales in Parkinson desease
changes in the Unified Parkinson's Disease Rating Scale scale (MDS-UPDRS) part I (mental section), part II (daily activities), part III, (motor section), and part IV (treatment complications). Overall range (Part I+II+III+IV): 0 to 260 Higher values represent a worse disease state
Time frame
up to 15 weeks2
Changes in the off periods in Parkinson desease
• variations in the off periods using the patient's personal diary
Time frame
up to 15 weeks3
Changes in the patients Clinical Global Impression in Parkinson desease
• changes in the patients Clinical Global Impression as measured by the Clinical Global Impression-Severity Scale (CGI-S). Range: 0 to 7 Higher values represent a worse disease state
Time frame
up to 21 weeks4
Changes in the quality-of-life in Parkinson desease
• changes in the quality-of-life scale with the Parkinson's Disease Questionnaire (PDQ39). Range: 0 to 100 Higher values represent a worse disease state
Time frame
up to 15 weeksSponsors and contacts
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Source ClinicalTrials.gov