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.
To evaluate safety and tolerability of CBD-based drug product at different doses
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
The following dose regime for the 4 treatment arms will be used: DOSE TITRATION PERIOD: First 5 days: 0.3 mL/day (1 dose) Subsequent 5 days: 0.6 mL/day (2 doses of 0.3 mL/dose) Subsequent 5 days: 0.8 mL/day (2 doses of 0.4 mL/dose) Last 5 days: 1 mL/day (2 doses of 0.4 mL/dose) PERIOD OF ACTIVE TREATMENT Continue with the last dose set by the titration schedule (for 12 weeks). PERIOD OF TREATMENT INTERRUPTION Medication is gradually discontinued every 7 days until complete termination. The first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.
The following dose regime for the 4 treatment arms will be used: DOSE TITRATION PERIOD: First 5 days: 0.3 mL/day (1 dose) Subsequent 5 days: 0.6 mL/day (2 doses of 0.3 mL/dose) Subsequent 5 days: 0.8 mL/day (2 doses of 0.4 mL/dose) Last 5 days: 1 mL/day (2 doses of 0.4 mL/dose) PERIOD OF ACTIVE TREATMENT Continue with the last dose set by the titration schedule (for 12 weeks). PERIOD OF TREATMENT INTERRUPTION Medication is gradually discontinued every 7 days until complete termination. The first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.
Hospital Español de Mendoza
Mendoza, Mendoza Province, Argentina
RECRUITINGNumber of patients with advers events related to treatment acording to CTCAE v5.0
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
Time frame: up to 21 weeks
Changes in differents motors scales in Parkinson desease
changes in the Unified Parkinson's Disease Rating Scale scale (MDS-UPDRS) part I (mental section), part II (daily activities), part III, (motor section), and part IV (treatment complications). Overall range (Part I+II+III+IV): 0 to 260 Higher values represent a worse disease state
Time frame: up to 15 weeks
Changes in the off periods in Parkinson desease
• variations in the off periods using the patient's personal diary
Time frame: up to 15 weeks
Changes in the patients Clinical Global Impression in Parkinson desease
• changes in the patients Clinical Global Impression as measured by the Clinical Global Impression-Severity Scale (CGI-S). Range: 0 to 7 Higher values represent a worse disease state
Time frame: up to 21 weeks
Changes in the quality-of-life in Parkinson desease
• changes in the quality-of-life scale with the Parkinson's Disease Questionnaire (PDQ39). Range: 0 to 100 Higher values represent a worse disease state
Time frame: up to 15 weeks
Changes in differents no motors symproms in Parkinson desease
• changes in non-motor symptoms by means of Non-Motor Symptom Scale (NMSS) and Non-Motor Symptoms Questionnaire (NMSQ).
Time frame: up to 15 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The following dose regime for the 4 treatment arms will be used: DOSE TITRATION PERIOD: First 5 days: 0.3 mL/day (1 dose) Subsequent 5 days: 0.6 mL/day (2 doses of 0.3 mL/dose) Subsequent 5 days: 0.8 mL/day (2 doses of 0.4 mL/dose) Last 5 days: 1 mL/day (2 doses of 0.4 mL/dose) PERIOD OF ACTIVE TREATMENT Continue with the last dose set by the titration schedule (for 12 weeks). PERIOD OF TREATMENT INTERRUPTION Medication is gradually discontinued every 7 days until complete termination. The first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.
The following dose regime for the 4 treatment arms will be used: DOSE TITRATION PERIOD: First 5 days: 0.3 mL/day (1 dose) Subsequent 5 days: 0.6 mL/day (2 doses of 0.3 mL/dose) Subsequent 5 days: 0.8 mL/day (2 doses of 0.4 mL/dose) Last 5 days: 1 mL/day (2 doses of 0.4 mL/dose) PERIOD OF ACTIVE TREATMENT Continue with the last dose set by the titration schedule (for 12 weeks). PERIOD OF TREATMENT INTERRUPTION Medication is gradually discontinued every 7 days until complete termination. The first 7 days dose will be reduced to 0.5 mL/day; on subsequent 7 days, dose will be reduced to 0.3 mL/day. If a patient has reached a maximum tolerated dose, dose reduction will be made at the discretion of the investigator.
Changes in depression in Parkinson desease
• changes in depression with the Beck Depression Inventory Scale (BDI-II). Overall range: 0 to 63. Higher values represent a worse disease state
Time frame: up to 15 weeks
Changes in sleep in Parkinson disease
• changes in the sleep scale for Parkinson Desease with Epworth Scale. Overall range: 0 to 24. Higher values represent a worse disease state
Time frame: up to 15 weeks
Changes in Cognitive Assessment in Parkinson desease
To assess the Montreal Cognitive Assessment (MoCA) scale Maximum score 30 Score greater than 26 is considered normal
Time frame: up to 15 weeks
Changes in apathy in Parkinson desease
• changes in apathy measured by the Apathy Evaluation Scale (AES). Total score ranges: 18 to 72 Higher scores indicating more apathy
Time frame: up to 15 weeks
Changes in pain in Parkinson desease
• DP pain-related changes measured by the King's Parkinson's Disease Pain Scale (KPSS). Range: 0 to 168 Higher values represent a worse disease state
Time frame: up to 15 weeks