Background & Aims

Parkinson disease (PD) is a neurodegenerative disorder that affects 6.1 million people worldwide. Since 1990, its age-adjusted prevalence has increased by around 22%. It is characterized pathophysiologically by the depletion of dopaminergic neurons and clinically by the appearance of extrapyramidal rigidity, tremor, and bradykinesia. It also causes non-motor symptoms (NMS) of different natures, which include pain, depressive mood, cognitive decline, autonomic symptoms, and sleep disorders. Chronic pain, in particular, occurs in 20% of cases at the time of diagnosis and in up to 80% throughout the disease. With the legalization of cannabinoids for medicinal use in several countries, there has been a significant increase in scientific interest in their potential benefit in the treatment of neurodegenerative conditions, in particular, Parkinson Disease. For this reason, we propose here a study to evaluate the efficacy and safety of using purified Cannabis extract, predominantly containing

Methods

This is a randomized, controlled, double-blinded clinical trial. Participants will be randomized into two groups: group A (experimental) and group B (control). Group A will receive a purified extract of Cannabis sativa L., containing cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC) <0.5%, diluted in an excipient of medium chain triglycerides (MCT) and ascorbyl acetate. Meanwhile Group B will receive a solution containing only the MTC excipient and ascorbyl acetate. Participants will be monitored via telephone; titration will occur in the first three weeks of follow-up, up to 43,88mg/day of CBD. Afterward, patients will be instructed to continue the use of the substance for another 6 weeks. Follow-up assessments will occur at 3, 6 and 12 weeks. The primary outcome will be the 30% response rate for average pain intensity reduction, as measured by the numeric rating scale.

Results

No results yet.

Conclusions

There are a growing number of observational studies and clinical trials that have investigated the role of cannabinoid use in treating the motor symptoms of PD. It is noted, however, that there is a lack of clinical trials that have specifically evaluated the effect of cannabinoid therapy in the treatment of NMS in PD.

References

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Presenting Author

Larissa Iulle Moreira

Poster Authors

Larissa Moreira

Lead Author

Gabriel Kubota

University of São Paulo Clinics Hospital

Lead Author

Manoel Teixeira

University of São Paulo School of Medicine

Lead Author

Daniel Ciampi de Andrade

Faculty of Medicine, Aalborg University

Lead Author

Topics

  • Access to Care