Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms
88 patients around the world
Available in Argentina
To evaluate safety and tolerability of CBD-based drug product at different doses
Laboratorio Elea Phoenix S.A.
1Research sites
88Patients around the world
This study is for people with
Extrapyramidal and movement disorders
Parkinson's disease
Requirements for the patient
To 80 Years
All Gender
Medical requirements
Participants between 40 and 80 years old.
Participants diagnosed with PD according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease and to the Brain Bank Criteria for Parkinson's disease, with mild to moderate disease as measured by the modified Hoehn and Yahr scale.
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.
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.
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 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 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 until at least four weeks after completion of study treatment.
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).