Clinical trial NCT06629389: Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms
Official title: Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate Safety and Tolerability of Cannabidiol (Kanbis®) for the Treatment of Parkinson&amp;#39;s Disease Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: parkinson disease
Cannabidiol
oil
cannabis
Lead sponsor: Laboratorio Elea Phoenix S.A.
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled
Primary purpose: TREATMENT

Brief 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 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\&#39;s disease (72), and to the Brain Bank Criteria for Parkinson\&#39;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\&lt;10g/dL, Leukocytes\&lt;4000 u/ml, Neutrophils\&lt;1500 u/ml, Lymphocytes\&lt;500u/ml, Platelets\&lt;100000 u/ml, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\&gt; 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).

Primary outcomes:
measure: Number of patients with advers events related to treatment acording to CTCAE v5.0
timeFrame: up to 21 weeks
Secondary outcomes:
measure: Changes in differents motors scales in Parkinson desease
timeFrame: up to 15 weeks
measure: Changes in the off periods in Parkinson desease
timeFrame: up to 15 weeks
measure: Changes in the patients Clinical Global Impression in Parkinson desease
timeFrame: up to 21 weeks
measure: Changes in the quality-of-life in Parkinson desease
timeFrame: up to 15 weeks
measure: Changes in differents no motors symproms in Parkinson desease
timeFrame: up to 15 weeks
measure: Changes in depression in Parkinson desease
timeFrame: up to 15 weeks
measure: Changes in sleep in Parkinson disease
timeFrame: up to 15 weeks
measure: Changes in Cognitive Assessment in Parkinson desease
timeFrame: up to 15 weeks
measure: Changes in apathy in Parkinson desease
timeFrame: up to 15 weeks
measure: Changes in pain in Parkinson desease
timeFrame: up to 15 weeks
Other outcomes:
Locations:
city: Mendoza
country: Argentina
facility: Hospital Español de Mendoza
Study officials:
affiliation: Hospital Español de Mendoza
name: Marina Sanchez Abraham, Neurologa
role: PRINCIPAL_INVESTIGATOR
References: