NCT06629389

Clinical Trial with Cannabidiol (Kanbis®) for Parkinson Disease Symptoms

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Laboratorio Elea Phoenix S.A. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Cannabidiol 100 mg/ml	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.
DRUG	cannabidiol 300 mg/ml	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.
DRUG	Cannabidiol 400 mg/ml	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.
DRUG	Placebo	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.

Timeline

• Start date: 2024-11-28
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2024-10-08
• Last updated: 2024-12-05

Locations

1 site across 1 country: Argentina