The Effect of Cannabidiol for Restless Legs Syndrome/Willis-Ekbom Disease in Parkinson's Disease Patients with REM Sleep Behavior Disorder: A <i>Post Hoc</i> Exploratory Analysis of Phase 2/3 Clinical Trial

Almeida, Carlos Maurício Oliveira de; Brito, Manuelina Mariana Capellari Macruz; Bosaipo, Nayanne Beckmann; Pimentel, Angela Vieira; Sobreira-Neto, Manoel Alves; Tumas, Vítor; Zuardi, Antônio Waldo; Crippa, José Alexandre de Souza; Hallak, Jaime Eduardo Cecílio; Éckeli, Alan Luiz

doi:10.1089/can.2021.0158

Cited by 5 publications

(5 citation statements)

References 13 publications

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“…In contrast with the findings of the uncontrolled studies, two larger RCTs with 33 patients each examined the symptoms associated with Parkinsons, and did not report any differences in the frequency of nights with RBD symptoms [23] or severity of associated restless leg syndrome [96] with oral CBD doses of 75-300 mg over 14 weeks. In an RCT that included 24 patients, symptoms associated with anxiety, including anxiogenic tremor, were improved with a single 300 mg dose of CBD in a simulated public speaking test in patients with Parkinson's disease (de Faria et al, 2020).…”

Section: Purified Cbd In Movement Disorders (Parkinson's Disease and ...mentioning

confidence: 58%

The therapeutic potential of purified cannabidiol

O’Sullivan,

Jensen,

Nikolajsen

et al. 2023

J Cannabis Res

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The use of cannabidiol (CBD) for therapeutic purposes is receiving considerable attention, with speculation that CBD can be useful in a wide range of conditions. Only one product, a purified form of plant-derived CBD in solution (Epidiolex), is approved for the treatment of seizures in patients with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. Appraisal of the therapeutic evidence base for CBD is complicated by the fact that CBD products sometimes have additional phytochemicals (like tetrahydrocannabinol (THC)) present, which can make the identification of the active pharmaceutical ingredient (API) in positive studies difficult. The aim of the present review is to critically review clinical studies using purified CBD products only, in order to establish the upcoming indications for which purified CBD might be beneficial. The areas in which there is the most clinical evidence to support the use of CBD are in the treatment of anxiety (positive data in 7 uncontrolled studies and 17 randomised controlled trials (RCTs)), psychosis and schizophrenia (positive data in 1 uncontrolled study and 8 RCTs), PTSD (positive data in 2 uncontrolled studies and 4 RCTs) and substance abuse (positive data in 2 uncontrolled studies and 3 RCTs). Seven uncontrolled studies support the use of CBD to improve sleep quality, but this has only been verified in one small RCT. Limited evidence supports the use of CBD for the treatment of Parkinson’s (3 positive uncontrolled studies and 2 positive RCTs), autism (3 positive RCTs), smoking cessation (2 positive RCTs), graft-versus-host disease and intestinal permeability (1 positive RCT each). Current RCT evidence does not support the use of purified oral CBD in pain (at least as an acute analgesic) or for the treatment of COVID symptoms, cancer, Huntington’s or type 2 diabetes. In conclusion, published clinical evidence does support the use of purified CBD in multiple indications beyond epilepsy. However, the evidence base is limited by the number of trials only investigating the acute effects of CBD, testing CBD in healthy volunteers, or in very small patient numbers. Large confirmatory phase 3 trials are required in all indications.

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Section: Purified Cbd In Movement Disorders (Parkinson's Disease and ...mentioning

confidence: 58%

The therapeutic potential of purified cannabidiol

O’Sullivan,

Jensen,

Nikolajsen

et al. 2023

J Cannabis Res

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“…However, these results were not confirmed in a placebo-controlled randomized trial in PD patients with Restless Legs Syndrome and RBD. In this study, treatment with CBD (doses gradually increasing from 75 to 300 mg for 12 weeks) did not result in improvements in subjective, nor in objective sleep quality measured by polysomnography, as compared to placebo (de Almeida et al, 2023).…”

Section: Parkinson's Diseasementioning

confidence: 63%

Cannabidiol and brain function: current knowledge and future perspectives

Schouten,

Dalle,

Mantini

et al. 2024

Front. Pharmacol.

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Cannabidiol (CBD) is a naturally occurring non-psychoactive cannabinoid found in Cannabis sativa, commonly known as cannabis or hemp. Although currently available CBD products do not meet the safety standards of most food safety authorities to be approved as a dietary supplement or food additive, CBD has been gaining widespread attention in recent years due to its various potential health benefits. While primarily known for its therapeutic effects in managing epileptic seizures, psychosis, anxiety, (neuropathic) pain, and inflammation, CBD’s influence on brain function has also piqued the interest of researchers and individuals seeking to enhance cognitive performance. The primary objective of this review is to gather, synthesize, and consolidate scientifically proven evidence on the impact of CBD on brain function and its therapeutic significance in treating neurological and mental disorders. First, basic background information on CBD, including its biomolecular properties and mechanisms of action is presented. Next, evidence for CBD effects in the human brain is provided followed by a discussion on the potential implications of CBD as a neurotherapeutic agent. The potential effectiveness of CBD in reducing chronic pain is considered but also in reducing the symptoms of various brain disorders such as epilepsy, Alzheimer’s, Huntington’s and Parkinson’s disease. Additionally, the implications of using CBD to manage psychiatric conditions such as psychosis, anxiety and fear, depression, and substance use disorders are explored. An overview of the beneficial effects of CBD on aspects of human behavior, such as sleep, motor control, cognition and memory, is then provided. As CBD products remain largely unregulated, it is crucial to address the ethical concerns associated with their use, including product quality, consistency, and safety. Therefore, this review discusses the need for responsible research and regulation of CBD to ensure its safety and efficacy as a therapeutic agent for brain disorders or to stimulate behavioral and cognitive abilities of healthy individuals.

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“…In a doubleblind, placebo-controlled study, Parkinson's patients with REM sleep disorders did not benefit from CBD administration (Almeida et al 2021). A post hoc analysis of the same study also showed no benefit in terms of additional restless legs symptoms (de Almeida et al 2023).…”

Section: Parkinsonmentioning

confidence: 98%

Therapeutic use of medical Cannabis in neurological diseases: a clinical update

Hidding,

Mainka,

Buhmann

2023

J Neural Transm

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The use of medical Cannabis has increased in recent years due to changing legal circumstances in many countries. Approval exists only for a few neurological conditions such as rare forms of epilepsy or spasticity in multiple sclerosis. Beyond that, however, medical Cannabis is used for a wide range of neurological conditions and symptoms. In Germany, in parallel with new legislation that has simplified the prescription of medical Cannabis, an accompanying survey has been implemented for which initial data are now available. In this context, our review provides an overview of the evidence for the therapeutic use of medical Cannabis in neurology, the potential benefits, and side effects.

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The Effect of Cannabidiol for Restless Legs Syndrome/Willis-Ekbom Disease in Parkinson's Disease Patients with REM Sleep Behavior Disorder: A Post Hoc Exploratory Analysis of Phase 2/3 Clinical Trial

Cited by 5 publications

References 13 publications

The therapeutic potential of purified cannabidiol

The therapeutic potential of purified cannabidiol

Cannabidiol and brain function: current knowledge and future perspectives

Therapeutic use of medical Cannabis in neurological diseases: a clinical update

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