Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms
ConditionParkinson Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorLaboratorio Elea Phoenix S.A.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cannabidiol 100 mg/ml
- cannabidiol 300 mg/ml
- Cannabidiol 400 mg/ml
- Placebo
Treatment groups
88 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov