NCT06629389
Recruiting
Phase 2
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
ConditionsParkinson Disease
Overview
- Phase
- Phase 2
- Intervention
- Cannabidiol 100 mg/ml
- Conditions
- Parkinson Disease
- Sponsor
- Laboratorio Elea Phoenix S.A.
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Number of patients with advers events related to treatment acording to CTCAE v5.0
- Status
- Recruiting
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants between 40 and 80 years old.
- •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).
- •Participants who have not changed their anti-Parkinson's drugs (or dose) at least one month prior to study entry.
- •Acceptance by the participant by signing the ICF.
- •Subjects capable of giving consent to participate in the study
Exclusion Criteria
- •Evidence of dementia, Mini-Mental State Exam score less than 24 or with previous diagnosis by cognitive assessment .
- •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.
- •Known or suspected allergy to cannabinoids or inactive ingredients used in the formulation of the study drug.
- •History of drug or alcohol dependence.
- •Use of dopamine blockers within 180 days prior to study entry.
- •Use of amphetamine inhibitors, cocaine and MAO-A inhibitors within 90 days prior to study entry.
- •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.
- •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.
- •Moderate-severe liver disease. (Child Pugh B-C)
- •Pregnant or breastfeeding.
Arms & Interventions
Group CBD 100
The following dose regime for the 4 treatment arms will be used
Intervention: Cannabidiol 100 mg/ml
Group CBD 300
The following dose regime for the 4 treatment arms will be used
Intervention: cannabidiol 300 mg/ml
Group CBD 400
The following dose regime for the 4 treatment arms will be used
Intervention: Cannabidiol 100 mg/ml
Group CBD 400
The following dose regime for the 4 treatment arms will be used
Intervention: Cannabidiol 400 mg/ml
Group Placebo
The following dose regime for the 4 treatment arms will be used
Intervention: Placebo
Outcomes
Primary Outcomes
Number of patients with advers events related to treatment acording to CTCAE v5.0
Time Frame: up to 21 weeks
Frequency of adverse events by a global comparison of all dose or placebo groups Range: 1 to 5 Higher values represent a worse disease state
Secondary Outcomes
- Changes in differents motors scales in Parkinson desease(up to 15 weeks)
- Changes in the off periods in Parkinson desease(up to 15 weeks)
- Changes in the patients Clinical Global Impression in Parkinson desease(up to 21 weeks)
- Changes in the quality-of-life in Parkinson desease(up to 15 weeks)
- Changes in differents no motors symproms in Parkinson desease(up to 15 weeks)
- Changes in depression in Parkinson desease(up to 15 weeks)
- Changes in sleep in Parkinson disease(up to 15 weeks)
- Changes in Cognitive Assessment in Parkinson desease(up to 15 weeks)
- Changes in apathy in Parkinson desease(up to 15 weeks)
- Changes in pain in Parkinson desease(up to 15 weeks)
Study Sites (1)
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