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

Inclusion Criteria:

1. Participants between 40 and 80 years old.

2. Participants diagnosed with PD according to Movement Disorder Society ClinicalDiagnostic Criteria for Parkinson's disease (72), and to the Brain Bank Criteriafor Parkinson's disease, with mild to moderate disease as measured by themodified Hoehn and Yahr scale. (Both clinical criteria are included since many ofthe study participants were diagnosed with previous criteria and others with currentcriteria, both of which are very similar and do not change or raise any doubt aboutthe diagnosis of the disease).

3. Participants who have not changed their anti-Parkinson's drugs (or dose) at leastone month prior to study entry.

4. Acceptance by the participant by signing the ICF.

5. Subjects capable of giving consent to participate in the study

Exclusion Criteria:

1. Evidence of dementia, Mini-Mental State Exam score less than 24 or with previousdiagnosis by cognitive assessment .

2. Severe psychiatric pathology: severe depression, treatment-refractory psychosis.Evaluation by psychiatrist who confirms the pathology. History of hospitalization ina psychiatric center or mental health center is an exclusion criterion regardless ofthe time spent since hospitalization or the reason for which the patient washospitalized.

3. Known or suspected allergy to cannabinoids or inactive ingredients used in theformulation 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 tostudy entry.

7. Patients who have received within 90 days prior to study entry the following drugsdue 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 methodof proven efficacy (diaphragm or partner using condom, oral or implanted hormonalcontraceptive; intrauterine device, stable partner with vasectomy), until at leastfour weeks after completion of study treatment. Pregnancy blood test will beperformed before starting the study.

12. Participants who have had a surgical procedure for PD, either deep brain stimulationor surgery for lesion.

13. Patients de novo or with recent diagnosis of PD (less than 5 years).