Research Projects

Clinical Trials for Better Outcomes

Two in three people with epilepsy gain seizure control but that still means that for one in three people, current medication won’t help fully control their seizures.

Rurther medical research is needed to find more effective treatments. Clinical trials are research investigations in which people volunteer to test new treatments to better prevent and manage medical conditions.

People with epilepsy are in a position to help others by participating in clinical trials that can contribute to medical knowledge and result in better treatment outcomes.

Participating in a clinical trial is a commitment and you need to be fully informed about the objectives of the research, what is expected of you and any risks and potential inconveniences that may be experienced during and after the trial.

Finding a Clinical Trial

• The Australian New Zealand Clinical Trials Registry (ANZCTR) lists current or recently completed epilepsy trials.
• The U.S. National Institutes of Health has listings of currently recruiting studies.

Clinical trials contribute to medical knowledge and the results of these studies can make a difference in the care of future people by providing information about the benefits and risks of medications, products or procedures.

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Current and Ongoing Research Projects

Australian Pregnancy Register: currently recruiting

The Australian Pregnancy Register (APR) is  an independent research project into the long-term effects and safety of anti-epileptic drugs (AEDs) on the mother and child during and after pregnancy. Epilepsy Action is a major partner and supporter of the APR.

This register is designed to bridge current knowledge gaps about epilepsy medication and has already identified some issues that has resulted in a change in prescribing practices and a reduced rate of birth defects.

To be eligible to participate, you need to answer yes to two of the following three questions:

Are you:

• Planning a pregnancy, currently pregnant or have recently given birth?
• Taking an antiepileptic medication with or without a diagnosis of epilepsy?
• Not taking antiepileptic medication but have been diagnosed with epilepsy?

The aim is to have as many women as possible enrol to provide a broad base of information. This is an observational study consisting of one to four brief telephone interviews and does not require any change to your current medication regime or treatment.

If you would like to contribute to the collective knowledge of AEDs and pregnancy please Register Here 

Are you interested in trialing medicinal cannabis?

Currently Recruiting

Conducted by researchers at the University of Sydney, the QUality of life Evaluation STudy (QUEST Initiative) will be investigating the quality of life and health economic impact of prescribed medicinal cannabis on Australians with chronic disease over 12 months. The study is open to Australians with a range of conditions including chronic pain, cancer pain, neuropathic pain, insomnia, anxiety, multiple sclerosis and epilepsy.

You cannot participate if you are currently receiving medicinal cannabis treatment.

To learn more about the study, go to: https://www.thequestinitiative.com/wp-content/uploads/2020/12/201202_QUEST_ParticpantInfoStatement.pdf

To find out if you are eligible, Click Here

Recruitment ends 31^st March 2022

Study on Medicinal Cannabis is investigating epilepsy: Currently Recruiting

Around 30% of people with epilepsy can’t achieve seizure control using conventional medications. Cannabidiol (CBD), a therapeutic and non-intoxicating constituent of cannabis, has recently been approved as an add-on therapy for the management of some treatment-resistant epilepsy disorders. Evidence suggests that medicinal cannabis can improve seizure management and may improve other quality-of life symptoms associated with epilepsy. However, more research is needed and studies are being conducted.

If you live with treatment-resistant epilepsy, you may be eligible to participate in a new Australia-wide observational study that is investigating the safety and efficacy of a high-quality (pharmaceutical-grade), non-intoxicating CBD-rich medicinal cannabis.

Participation in the study involves answering questionnaires about your health-outcomes and response to the medication through the study app or website for the duration of the study (up to 12 months).

If you join the study you will be provided the medicine at subsided cost, with the first two bottles (25mL) provided at approximately $30 each to cover pharmacy dispensing fees. Normal clinic consultation fees will be covered by you, a portion of the costs may be eligible for MediCare rebates.

The results from this study will be used to help improve accessibility and a full record of your study results will be made available to you and your doctor to support your care.

Visit the study website for more information: Clinical Research – Bod Pharmaceuticals

Cannabinoid Medicine Observational Study (CMOS): currently recruiting

Applied Cannabis Research (ACR), is commencing Australia’s largest observational study ever undertaken for medical cannabis. ACR will lead the study in conjunction with Australia’s medical community and key industry partners.

Working with clinical collaborators from major clinics and hospitals, the Cannabinoid Medicine Observational Study (CMOS)  will collect data from 20,000 patients nationwide over 5 years, to assess the safety and efficacy of medicinal cannabis products for a range of conditions including fibromyalgia, chronic pain syndromes, epilepsy and other neurological conditions, PTSD and other mental illness.

CMOS provides a first-of-its-kind opportunity to capture data from a broader range of Australian prescribers and patients than in existing studies. Australia’s Therapeutic Goods Administration (TGA) has now approved over 67,000 applications for medical cannabis. With a lack of randomised clinical trials, there is an urgent need for large-scale evidence-based studies of prescribing medicinal cannabis. Feedback on treatment-related progress, dosing and side-effects is becoming increasingly relevant.

Key Highlights:

• Some subsidised medicinal cannabis products may be available for study participants
• Data is collected through progress-related questionnaires over a 12-month period about efficacy, side effects, dosage, adherence to medication, changes to other medications and progressing health status
• Patients may be asked to complete separate surveys according to relevant indications to monitor conditions such as pain, anxiety, depression, fatigue, sleep disorders, and physical function
• Data is collected from both treating doctors and patients to provide a complete view of their medical cannabis journey
• Data collected will be periodically fed back to participating doctors to inform patient care and for teaching purposes
• Patients are only identified by a unique study ID number

The CMOS study is open to both doctors and patients to get involved and can register their interest through either Patient or Doctor tab on the bottom of the page found here

People with epilepsy can register themselves into this study and do not need their treating doctor to register them.

Interested doctors, clinics or researchers can find out more about CMOS and register their interest here. 

Examining the efficacy of an online Cognitive Behaviour Therapy (CBT) – based self-management program for adults with neurological disorders

Macquarie University’s eCentreClinic is looking for adults with epilepsy to take part in a free online course to help Australians with neurological conditions learn to manage:

• Stress, anxiety, frustration and worry.
• Low mood, sadness, grief and depression.
• Day-to-day mental or cognitive activities.
• Day-to-day physical activities.

Click here to find out more about this Wellbeing Neuro Course and current research trial

Quality of life in children with a genetically caused epilepsy disorder: currently recruiting

Researchers at the Telethon Kids Institute would like to talk with parents of children with a genetically caused epilepsy disorder. We wish to find out what challenges or helps quality of life. Findings will help researchers better determine how the lives of these children and their families can be improved.

Participants will be interviewed and it will take approximately one hour over the phone or online.

Who can take part?

Any parent of a child aged 2-18 years with a genetically caused epilepsy disorder

Contact for more information

Associate Professor Jenny Downs [email protected] phone (08) 6319 1763

Approved by Curtin University Human Research Ethics Committee (HREC) HRE2020-0687

CACOS – Epilepsy: currently recruiting

The Cannabis Access Clinics Observational Study: Observation of safety and health-related outcomes in patients with epilepsy undergoing medicinal cannabis therapy (CACOS-Epilepsy) has been ethics approved by Bellberry HREC Protocol No.2019-06-502.

This study will monitor several safety and health-related measures of patients engaged in medicinal cannabis treatment at Cannabis Access Clinics. This will help gain a better understanding of the role of medicinal cannabis in treating various health conditions including epilepsy and help shape future clinical trials.

This observational study follows the journey of patients with epilepsy using the usual services of Cannabis Access Clinics, the only difference is patients may volunteer and consent to complete a number of surveys and have their data de-identified and included in the analysis to inform improvements in clinical care. As an observational study, there will be no changes to the type of medicine or dosages you are prescribed.

If you would like to participate or simply want more information please contact Epilepsy Action Australia via [email protected] or Cannabis Access Clinic study team on 1300 991 477 or email [email protected]

‘Absent voices’ (Study 1 Families): closed

Feasibility study exploring whole family experiences of living with parental refractory epilepsy to inform service development

‘Absent voices’ (Study 2 Expert Panel): closed

Feasibility study exploring whole family experiences of living with parental refractory epilepsy to inform service development

Preliminary findings showed:

• Each family verified life has been impacted, particularly socially and psychologically.
• They confirmed a general lack of awareness and understanding on the impact of parental epilepsy on family function and dynamics, which added to the stress of family life.
• Children’s roles and responsibilities vary in families, but most could be considered as young carers.

These studies are no longer recruiting. Data will be available soon.

PELICAN – Paediatric Epilepsy Lambert Initiative Cannabinoid Analysis: closed

Epilepsy Action Australia has joined forces with the Lambert Initiative, Sydney University to further our understanding of the benefits and issues faced by parents who would like to, have previously or are currently administering various forms and formulations of medicinal cannabis to their child with epilepsy.

This research will help us better understand key issues and obstacles families face in the decision to use or not use cannabis for their child’s epilepsy, and to identify the types of cannabinoids present in artisanal oils and tinctures being used to treat seizures in children.

This research study is no longer recruiting. 

Read here for results to date

Find further information about this study here

SEISMIC: Sydney Epilepsy Incidence Study to Measure Illness Consequence: closed

Epilepsy Action Australia and The George Institute for International Health have undertaken a major epidemiological research project to measure the impact and incidence of epilepsy.  SEISMIC explored the incidence, psychosocial impact and the household economic burden of epilepsy in a large population.

The resulting paper called Frequency and predictors of psychological distress after a diagnosis of epilepsy: A community-based study was released in 2017 and found that anxiety and depression is common and fluctuates in frequency after a diagnosis of epilepsy.

Key findings include:

• Psychological distress (i.e. anxiety and depression) occurred in 33% and 24% of 180 adults when first diagnosed, and after 12 months respectively
• 23% of 77 children felt psychological distressed at diagnosis and remained so 12 months later
• Low household income, economic hardship, other illness, frequent seizures, and stigma are risk factors for psychological distress.
• Those who had psychological, psychosocial, and family problems before they were diagnosed with epilepsy are at high risk of this adverse outcome.

This study recruited and followed up people with newly diagnosed epilepsy living or being treated in the Sydney South West Area Health Service over a 3 year period.

This research study is no longer recruiting.

For further information about this study, click here

Other Research in Australia

The following hospital and university-based groups conduct epilepsy-related medical research in Australia:

Epilepsy and Neuropharmacology Research Group, Royal Melbourne Hospital, The University of Melbourne: covers both basic and clinical studies relevant to epilepsy and related areas, including traumatic brain injury.

The Florey Institute of Neuroscience and Mental Health: one of the world’s top 10 brain research centres made up of four medical research institutes uniting to find cures for brain disease, including Howard Florey Institute, the Mental Health Research Institute, the National Stroke Research Institute and the Brain Research Institute.

Epilepsy Research Centre, Austin Hospital, Melbourne: comprises clinical researchers and scientists from research teams at the University of Melbourne, Austin Health and the Brain Research Institute working together to better understand the causes, treatment and outcome of epilepsy.

Neuroscience and Neurology Research Group, Monash University: features an Epilepsy Research Group focused on a range of issues.
Centre for Neuroscience, Flinders University, South Australia: its Brain Signals Laboratory is a high-level neurophysiological research unit with a special focus on epilepsy.