Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms

Exclusion Criteria

• •1. Evidence of dementia, Mini-Mental State Exam score less than 24 or with previous diagnosis by cognitive assessment .
• •2. 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.
• •3. Known or suspected allergy to cannabinoids or inactive ingredients used in the formulation of the study drug.
• •4. History of drug or alcohol dependence.
• •5. Use of dopamine blockers within 180 days prior to study entry.
• •6. Use of amphetamine inhibitors, cocaine and MAO-A inhibitors within 90 days prior to study entry.
• •7. 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.
• •8. 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.
• •9. Moderate-severe liver disease. (Child Pugh B-C)
• •10. Pregnant or breastfeeding.
• •11. 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.
• •12. Participants who have had a surgical procedure for PD, either deep brain stimulation or surgery for lesion.
• •13. Patients de novo or with recent diagnosis of PD (less than 5 years).