Clinical Trial with Cannabidiol (Kanbis®) for Parkinson D... | NCT06629389

NCT06629389

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group CBD 100	Active Comparator	The following dose regime for the 4 treatment arms will be used	Drug: Cannabidiol 100 mg/ml
Group CBD 300	Active Comparator	The following dose regime for the 4 treatment arms will be used	Drug: cannabidiol 300 mg/ml
Group CBD 400	Active Comparator	The following dose regime for the 4 treatment arms will be used	Drug: Cannabidiol 100 mg/ml Drug: Cannabidiol 400 mg/ml
Group Placebo	Placebo Comparator	The following dose regime for the 4 treatment arms will be used	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cannabidiol 100 mg/ml	Drug	The 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	up to 21 weeks

Secondary Outcomes

Measure	Description	Time Frame
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	up to 15 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
Subjects capable of giving consent to participate in the study

Exclusion Criteria:

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.
Use of dopamine blockers within 180 days prior to study entry.
Use of amphetamine inhibitors, cocaine and MAO-A inhibitors within 90 days prior to study entry.
Patients who have received within 90 days prior to study entry the following drugs due to drug interactions: valproic acid, felbamate, niacin (nicotinic acid) at doses ≥2000mg/day or nicotinamide (nicotinic acid amide or nicotinamide) at doses ≥3000mg/day, isoniazid, ketoconazole and/or clobazam.
Unstable medical condition detected by the following laboratory alterations: Hemoglobin<10g/dL, Leukocytes<4000 u/ml, Neutrophils<1500 u/ml, Lymphocytes<500u/ml, Platelets<100000 u/ml, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> 3 times the upper limit of normal.
Moderate-severe liver disease. (Child Pugh B-C)
Pregnant or breastfeeding.
Women of reproductive age who do not agree to use at least one contraceptive method of proven efficacy (diaphragm or partner using condom, oral or implanted hormonal contraceptive; intrauterine device, stable partner with vasectomy), until at least four weeks after completion of study treatment. Pregnancy blood test will be performed before starting the study.
Participants who have had a surgical procedure for PD, either deep brain stimulation or surgery for lesion.
Patients de novo or with recent diagnosis of PD (less than 5 years).

Name	Role	Phone	Extension	Email
Maria Daniela Di Leo, MD	Contact	1144898300		daniela.dileo@elea.com
Marcelo A Tinelli, MD	Contact	1144898300		marcelo.tinelli@elea.com

ID	Term
D010300	Parkinson Disease
D002189	Marijuana Abuse

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D002185	Cannabidiol
C587251	nabiximols

ID	Term
D002186	Cannabinoids
D013729	Terpenes
D006838	Hydrocarbons
D009930	Organic Chemicals