Using Cannabidiol to Treat Symptoms of Parkinson Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and tolerability of a cannabidiol-based drug product in patients with Parkinson Disease. Participants will receive different doses of cannabidiol or a placebo to assess its effects on motor and non-motor symptoms associated with the disease. The study aims to determine the optimal dosage that can provide therapeutic benefits while ensuring safety. It includes individuals diagnosed with mild to moderate Parkinson Disease who have stable medication regimens.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants between 40 and 80 years old.
2. 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).
3. Participants who have not changed their anti-Parkinson's drugs (or dose) at least one 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 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).

Where it's running

• Hospital Español de Mendoza
  Mendoza, Mendoza Province, Argentina Recruiting

Study contacts

• Principal investigator: Marina Sanchez Abraham, Neurologa — Hospital Español de Mendoza
• Study coordinator: Maria Daniela Di Leo, MD
• Email: daniela.dileo@elea.com
• Phone: 1144898300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.