Medicinal cannabis in neurodegenerative disorders: an open label, dose finding, safety and efficacy study

Abstract

Aim: Currently, there exist no curative treatments for neurodegenerative disorders. Recently, there has been a resurgence of interest in the use of medicinal cannabis to improve neurological conditions. Methods: A 12-month, open label, dose-finding, safety and efficacy study was conducted including 48 subjects with a variety of neurodegenerative disorders. Results: In our participants, we observed a reduction in pain, improved sleep, enhanced well-being and less agitation. Conclusion: Our findings suggest that medicinal cannabis might be useful in patients with neurodegenerative disorders in controlling pain, enhancing sleep, reducing difficult behaviors, controlling unusual and complex symptoms when other treatments have failed – this offers medicinal cannabis a role in palliation.

Summary points

• There are currently no curative treatments for neurodegenerative disorders.

• Recently there has been a resurgence of interest in the application of medicinal cannabis to neurological conditions.

• This study explores the role of medicinal cannabis in neurodegenerative disorders in an open label, dose-finding, safety and efficacy study.

• Over a 12-month interval, 48 subjects with a variety of neurodegenerative disorders were studied with 25 active participants: Parkinson's disease (PD) = 7, progressive supranuclear palsy (PSP) = 5, Alzheimer's disease (AD) = 4, secondary progressive multiple sclerosis (2°PMS) = 3, Huntington's disease (HD) = 3, multiple system atrophy (MSA) = 2 and fronto-temporal dementia (FTD) = 1.

• For various reasons, 23 withdrew from the study. The most common reason for withdrawal was lack of effect. The median dose of medicinal cannabis 10:10 (THC mg/ml: CBD mg/ml) was 1.0 ml; the mode = 0.75 ml with the range 0.5–3.0 ml.

• There were no limiting side effects.

• We did not observe any effect on markers of the natural history of the neurodegenerative processes in any of the conditions studied.

• We did observe a reduction in pain in PSP, 2°PMS and MSA.

• There were trends toward improved well-being in HD, AD, PSP, 2°PMS and MSA. Subjectively, 14/25 participants had improved sleep.

• A patient with PSP had reduction in agitation, insomnia, scratching behavior, exaggerated grasp responses and utilization behavior.

• A patient with HD saw the resolution of distressing intractable tongue biting.

• Medicinal cannabis may be useful in treating pain, sleep and behavior in patients with neurodegenerative disorders, and probably has a role in palliation.

Keywords: :

• medicinal cannabis
• neurodegenerative disorders
• open label
• pain
• sleep

Author contributions

PK Panegyres conceived and designed the study, analyzed and interpreted the data, drafted the manuscript and approved the final version; KL Lind monitored patients and collected efficacy data; CA MacFarlane monitored patients, collected efficacy data and edited manuscript; and AL Gurney collated and analyzed data.

Financial disclosure

This work was supported by Neurodegenerative Disorders Research Pty Ltd; no external funding or government grants were received for this research. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval (NDR HREC #170710) or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Additional information

Funding

This work was supported by Neurodegenerative Disorders Research Pty Ltd; no external funding or government grants were received for this research. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.