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RECRUITINGPHASE2

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

Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate Safety and Tolerability of Cannabidiol (Kanbis®) for the Treatment of Parkinson&#39;s Disease Symptoms

NCT06629389•Laboratorio Elea Phoenix S.A.

View on ClinicalTrials.gov

Summary

Parkinson disease (PD) is a chronic, progressive neurodegenerative disorder characterized by clinical motor and non-motor symptoms. Knowing the potential benefits has led to the use of cannabis as an alternative therapy.

Detailed Description

To evaluate safety and tolerability of CBD-based drug product at different doses

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Locations (1)

Hospital Español de Mendoza

Mendoza, Mendoza Province, Argentina

Key Dates

Start Date

November 28, 2024

Primary Completion Date

November 1, 2025

Completion Date

November 1, 2026

Last Updated

December 5, 2024

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease

Interventions

Cannabidiol 100 mg/ml

DRUG

cannabidiol 300 mg/ml

DRUG

Cannabidiol 400 mg/ml

DRUG

Placebo

DRUG

Contacts

Maria Daniela Di Leo, MD

CONTACT

1144898300 daniela.dileo@elea.com

Marcelo A Tinelli, MD

CONTACT

1144898300 marcelo.tinelli@elea.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

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