A clinical trial is a research study which tests new treatments and medicines. These tests are vital to determine medication side effects and effectiveness for managing different medical conditions. Doctors rely on the outcomes of clinical trials when making decisions about prescribing medication and other treatments for their patients.
Many people like to volunteer to participate in clinical trials knowing that their involvement is contributing to a body of knowledge that will ultimately help people with the condition.
There are strict rules in Australia governing research activities and approval, and it is important to know that:
Below are a number of clinical trials that Epilepsy Action Australia supports. The listed research projects may be at different stages including: recruiting for participants,
This study is specifically testing two different doses of cannabidiol on reducing insomnia symptoms.
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University of Sydney
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Australian Trial: This is a collaboration between the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney; and Orygen, the National Centre of Excellence in Youth Mental Health. This study is only open to those located in Victoria, Western Australian or Queensland.
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Melbourne Brain Centre
The GW Pharmaceuticals partnership has allowed NSW children and young people with the rare disorder Tuberous Sclerosis Complex (TSC) to take part in the GW-sponsored international clinical trial evaluating the use of Epidiolex® in treating their seizures. This Phase III global study, allows 210 patients access to Epidiolex®, in which 12 children in NSW are participating, through the SCHN, Clinical Research Centre.
An up-to-date summary of the benefits and harms of cannabis-based products for epilepsy in children.
International Clinical Trial
International Clinical Trial
University of Melbourne, Lambert Initiative for Cannabinoid Therapeutics
GW Research Ltd
Sydney Children’s Hospital Network
This paper aimed to systematically examine the efficacy and adverse event profile of cannabidiol and medicinal cannabis.
The Lambert Initiative at the University of Sydney, Royal Prince Alfred.
The Lambert Initiative at the University of Sydney, Royal Prince Alfred Hospital and Tilray.
The Lambert Initiative at the University of Sydney and South East Sydney Local Health District.
Recruitment: Closed
Study: Dravet Syndrome – Clinical Trial (International)
Research Collaborators: GW Pharmaceuticals
About the Study: International trial evaluating the use of Epidiolex® in treating Dravet Syndrome
Recruitment: Closed
Study: Tuberous Sclerosis Complex (International)
Research Collaborators: GW Pharmaceuticals
About the Study: International clinical trial evaluating the use of Epidiolex® in treating their seizures.
This Phase III global study, allows 210 patients access to Epidiolex®, in which 12 children in NSW are participating, through the SCHN, Clinical Research Centre
Publication: Pending
Recruitment: Expected April 2020
Study: A Double-blind, Placebo-controlled Study Investigating the Safety, Tolerability, Efficacy and Pharmacokinetics of EP1, an Enriched Cannabidiol Oil, in Children and Adolescents with Medication Resistant, Refractory Epilepsy
Research Collaborators: Melbourne Brain Centre (contact Mr Paul Lightfoot), Cann Pharmaceutical Aust Ltd Ltd
About the Study: The study will aim to determine if EP1 is an effective treatment for refractory epilepsy in children, adolescents and young adults by comparing different doses of EP1 against a placebo by measuring seizure frequency and character.
Publication: Pending
Recruitment: Open for Health Care Professionals and Patient Survey
Study: Australia Medicinal Cannabis Study
Research Collaborators:
About the Study: The surveys collect information focusing on the patterns of use, effectiveness and safety of medicinal cannabis products prescribed in Australia. The results of this study will be made available to researchers for further analysis and provide much needed information to guide policy decisions relating to medicinal cannabis in Australia.
The Australian Medicinal Cannabis Study began in late 2018 and will recruit participants over a 3 year period, with final surveys completed 15 months later.
Publication: Pending
Recruitment: Closed
Study: GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults with Dravet Syndrome
Research Collaborators: GW Research Ltd
About the Study: International study to investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
Publication: Pending
The NSW Government has committed $3.5 million towards research into the use of cannabis medicines for children with severe, treatment-resistant refractory epilepsy. A Compassionate Access Scheme and clinical trials are underway.
Recruitment: Enrolments commenced early 2019 and are ongoing (speak with your neurologist)
Study: Rett Syndrome Clinical Trial
Research Collaborators: Sydney Children’s Hospital Network
About the Study: Aims to evaluate the long-term safety and efficacy of a new cannabis medicine called Cannabidivarin (CBDV).
Publication: Pending
Newly available evidence supports earlier findings that cannabidiol probably reduces the frequency of seizures among children with drug-resistant epilepsy.
Findings:
CBD treatments were effective compared with placebo, regardless of the dose administered.
The safety analysis is related to tolerable side effects found in studies with both CBD and medicinal cannabis.
There was a greater tendency for side effects in short-term treatment compared with long-term treatment.
Recruitment: Closed
Study: Exploring the effects of THC and CBD on simulated driving.
Research Collaborators: The Lambert Initiative at the University of Sydney, Royal Prince Alfred Hospital and Tilray.
Chief Investigators: Professor Iain McGregor (Lambert Initiative, University of Sydney)
Completed: 2018
About the Study: This study explores the idea that CBD content in cannabis plant material will modify the effects of THC on driving, and investigates the link between concentrations of cannabinoids in blood and saliva, and driving ability. Drug testing of saliva and blood followed current Australian police procedures. A secondary aim of the study was to examine the relationship between positive results on these tests and actual driving impairment, currently a very controversial topic in the community and in legal circles.
Publication: Pending
Recruitment: Closed
Study: Knowledge and attitudes of Australian general practitioners towards medicinal cannabis.
Research Collaborators: The Lambert Initiative at the University of Sydney and HealthEd.
Chief Investigators: Professor Iain McGregor (Lambert Initiative, University of Sydney)
Completed: 2018
About the Study: A cross-sectional survey completed by 640 Australian General Practioners attending multiple-topic educational seminars in five major Australian cities between August and November 2017 was undertaken to assess the knowledge and attitudes of these clinicians toward medicinal cannabis.
Results: The majority of GPs (61.5%) reported one or more patient enquiries about medicinal cannabis in the past three months. Most felt that their own knowledge was inadequate and only 28.8% felt comfortable discussing medicinal cannabis with patients. Over half (56.5%) supported availability on prescription, with the preferred access model involving trained GPs prescribing independently of specialists. Support for use of medical cannabis was condition-specific, with strong support for use in cancer pain, palliative care and epilepsy, and much lower support for use in depression and anxiety.
Publication: https://bmjopen.bmj.com/content/8/7/e022101
Recruitment: Closed
Study: Cannabis as Medicine Survey (CAMS16)
Research Collaborators: The Lambert Initiative at the University of Sydney and South East Sydney Local Health District.
Chief Investigators: Professor Nick Lintzeris (South East Sydney Local Health District)
Completed: 2018
About the Study: The CAMS (Cannabis As Medicine Survey) is the first large scale survey of medicinal cannabis users in Australia for more than a decade. The objective of this survey is to create a national snapshot of the demographics of medical cannabis consumers, the conditions being treated, patterns of cannabis use, perceived efficacy, and the physical and mental health of consumers. In 2016, the CAMS study surveyed 1,749 Australians who reported using cannabis for medicinal purposes.
Results: Results indicated that the primary conditions being treated included anxiety (50.2%), back pain (49.4%), depression (48.8%), and sleep conditions (43%). Inhaled route was the most common routes of administration. A third of patients spent $0-$50 on cannabis, suggesting a sizeable proportion of home grown supply. Respondents self-reported overwhelmingly positive changes in the primary health condition being treated as a result of cannabis use, with more than 90 percent of respondents reporting an improvement.
Publication: https://onlinelibrary.wiley.com/doi/full/10.5694/mja17.01247
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