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New treatment option for Parkinson Disease
Official title Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms
ClinicalTrials.gov ID: NCT06629389
What this study is testing
What is Cannabidiol 100 mg/ml?
Cannabidiol 100 mg/ml is an investigational medicine, being studied as a potential treatment for parkinson disease.
Also referred to as CBD, Cannabis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
- 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.
- people capable of giving consent to participate in the study
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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.
- people capable of giving consent to participate in the study
- 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...
- 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...
- Unstable medical condition detected by the following laboratory alterations: Hemoglobin\ 3 times the upper limit of normal.
- Moderate-severe liver disease. (Child Pugh B-C)
- Pregnant or breastfeeding.
- Women of reproductive age who do not agree to use at least one contraceptive method of proven how well it works (diaphragm or partner using condom, oral or implanted hormonal contraceptive; intrauterine device, stable...
- Participants who have had a surgical procedure for PD, either deep brain stimulation or surgery for lesion.
- Patients de novo or with recent diagnosis of PD (less than 5 years).
The study team makes the final eligibility decision.
Where it's taking place
- Mendoza, Mendoza Province, Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mendoza, Mendoza Province, Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.