Using Cannabidiol to Treat Symptoms of Parkinson Disease

Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate Safety and Tolerability of Cannabidiol (Kanbis®) for the Treatment of Parkinson's Disease Symptoms

This study is testing if a cannabidiol-based treatment can help people with mild to moderate Parkinson's disease feel better by looking at different doses and their effects on symptoms.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Laboratorio Elea Phoenix S.A. (Industry-sponsored)
• Locations: 1 site (Mendoza, Mendoza Province)
• Trial ID: NCT06629389 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 80 diagnosed with mild to moderate Parkinson Disease.

Not a fit: Patients with severe psychiatric disorders or significant cognitive impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for managing symptoms of Parkinson Disease.

How similar studies have performed: Other studies have shown promising results with cannabidiol for various neurological conditions, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Mendoza, Mendoza Province

• 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

Conditions Parkinson Disease; parkinson disease; Cannabidiol; oil; cannabis