Clinical Trials

Knee Osteoarthritis Gene Therapy Clinical Trial

The ICM 20-1001 trial is looking to test a potential new gene therapy treatment for osteoarthritis. The potential new treatment is called ICM‑203. The treatment may help to form new cartilage and reduce any inflammation in your knee joint. ICM‑203 is injected directly into the knee joint.

ICM-203 is being tested in a placebo-controlled trial. The purpose of a placebo-controlled trial is to learn more about the safety and how a potential new treatment works, by comparing it to a medication that has no active ingredients (placebo). In this study, there is a 75% chance you will receive the new treatment and a 25% chance you will receive placebo.

You may be eligible to take part if you 

• Are between 50 and 80 years of age
• Have pain associated with mild or moderate knee osteoarthritis

If you take part, you can maintain your usual treatment for symptoms associated with knee osteoarthritis and for other medical problems.

If you are interested in participating, please contact Dr Kirsten Porter, Orthopaedic Research Coordinator, on (03) 4215 2208 or [email protected]

 

Help test and improve the Brain Tumours Online website as part of a research study

What is Brain Tumours Online? Brain Tumours Online is a website that was co-designed by patients, carers and health care professionals to provide reliable information, self-care tools, and a supportive community for people living in Australia affected by a primary brain tumour. You can watch a short video to see what the website looks like: https://vimeo.com/845785665/9aa1858ae0?share=copy

Who are we looking to recruit: We are seeking adults living in Australia who are affected by a primary brain tumour (or brain cancer), including:

• Patients with a brain tumour,
• Carers/family members of a patient with a brain tumour,
• Health care professionals who treat patients with brain tumour.

Patients can be at any stage since diagnosis. Carers can be family members or friends who care for an adult with a primary brain tumour diagnosis. They may be actively caring for someone with a brain tumour, or they may have provided care in the past for someone with a brain tumour.

What does participating in the study involve? We want you to use the Brain Tumours Online website and give us feedback on what you think of it, what worked well, and how it could be improved. Your use of the website will be monitored by web analytics, and you will also be sent online surveys to complete. Surveys will be sent before you start using the website, and at 3 months and 6 months after you first use the website, so researchers can evaluate how useful and effective Brain Tumours Online is. More details about the study can be found in the Participant Information and Consent Form available on the Brain Tumours Online website: https://braintumoursonline.org

To find out more information about the study, including eligibility criteria, and to sign up, please visit: https://braintumoursonline.org

Ethics statement: This study received ethics approval from the Royal Melbourne Hospital Human Research Ethics Committee (REF: HREC/89522/MH-2022), and Research Governance Approval from Barwon Health (REF: SSA/89522/VICBH-2023-379239).

 

Do you suffer from knee osteoarthritis pain and have excess weight to lose?

Barwon Health is currently conducting a clinical trial to examine the use of an investigational medication and its impact on weight management and knee osteoarthritis pain.

You may be eligible to take part in this study if:

• You have a BMI of > 27
• You are aged 18 years or over
• You have knee osteoarthritis pain
• You are not able to lose weight on your own

For more information please contact the Research Nurse, Anne Welsh on 03 4215 2879 or [email protected]

 

This study has been approved by Monash Health HREC.

Do you suffer from Cardiovascular Disease and have excess weight to lose?

Barwon Health is currently conducting a clinical trial to examine the use of an investigational medication and its impact on weight management.

You may be eligible to take part in this study if:

• You have a BMI of > 35
• You are aged 18 years or over
• You have known Cardiovascular Disease (heart attack, stroke or narrowed blood vessels)
• You are not able to lose weight on your own

For more information please contact the Research Nurse, Fahriya Zandari on 03 4215 2877 or [email protected].

This study has been approved by Monash Health HREC

 

Trial to test surgical repair of the torn rotator cuff in the shoulder

The ARC Trial is a clinical trial that will compare arthroscopic shoulder surgery where the rotator cuff tear is repaired, to the same surgery without repairing the rotator cuff. This research project is testing whether surgery to repair the tear is an effective treatment to improve shoulder pain and function and quality of life in people with rotator cuff tears.

You may be eligible to take part in the trial if you:

• Are aged between 45-75 years old
• Have been suffering from shoulder problems for the last six months
• Have been diagnosed as having a reparable rotator cuff tear, which was confirmed by an MRI imaging scan

To find out more, please contact Dr Kirsten Porter, Orthopaedic Research Coordinator, on (03) 4215 2208 or [email protected]

This study has ethical approval from UNSW Human Research Ethics Committee

Trial to explore best method for shoulder replacement surgery

Recruitment is starting soon for the RAPSODI-AUS study, which compares two common types of shoulder replacement: the Total Shoulder (Anatomic) replacement, and the Reverse Shoulder replacement. These are the two types of shoulder replacement that surgeons use very often for patients with osteoarthritis who need a shoulder replacement. They both help to reduce pain and maintain or improve movement, and the aim of this study is to explore which method works best.

You may be eligible to take part in the trial if you:

• Are aged 60 years and over
• Have been diagnosed as having shoulder osteoarthritis
• An intact rotator cuff (determined via pre-operative advanced imaging)

To find out more, please contact Dr Kirsten Porter, Orthopaedic Research Coordinator, on (03) 4215 2208 or [email protected]

This study has ethical approval from Metro North Health Human Research Ethics Committee

 

HARMON-E Study of lifestyle changes for reducing symptoms of depression

What is the HARMON-E study?

The HARMON-E trial is a group-based, telehealth clinical trial designed to support positive lifestyle changes to improve mental health for adults who are experiencing depression or bipolar disorder. HARMON-E is based on well-established evidence for lifestyle interventions as effective strategies for improving depressive symptoms and common associated physical health conditions. 

How are we doing this study?

We are recruiting 378 people (18+) from across Australia to participate in this study. Participants are randomly allocated into one of two programs: 1) led by allied health professionals and 2) led by clinical psychologists. Each program is 8 weeks long and we will measure changes in depressive symptoms over this period and compare them between the two groups.

Participants are asked to: 

• Join one 30-minute one-on-one introductory session with their interventionist via video call (Zoom)
• Join six 90-minute mental health therapy sessions via video call with a group of up to 7 other people (the same group each time)
• Answer questions in 5 one-on-one interviews over zoom about your health and wellbeing
• Make 2 visits to your local pathology to have a blood test and your height and weight measured
• Collect 2 stool samples at home

What are we hoping to find? 
The trial aims to determine whether a lifestyle-based approach to mental health care is as good as psychotherapy for reducing symptoms of depression.

Interested in participating?

If you are interested in participating you can complete a quick, 5 minute online pre-screening survey to see if you may be eligible.
The survey can be found here: HARMON-E Trial prescreening survey (deakin.edu.au)

You can contact the HARMON-E Team at [email protected] or 03 5227 2380
Food & Mood Centre,IMPACT Institute, Deakin University,  www.foodandmoodcentre.com.au

 

Negative symptoms of schizophrenia study

We are currently seeking participants for a study investigating the negative symptoms of schizophrenia

The study will be conducted at the Adrian Costa Clinical Trials Centre in Geelong and consists of a single appointment that includes:

• An interview to discuss your mental health.
• Taking of your blood for later testing.
• Cognitive tasks to assess your memory, attention, and processing speed.
• Measurement of weight, height, and blood pressure.

Inclusion criteria:

• Age 18+ years
• A clinical diagnosis of a psychotic disorder such as schizophrenia, schizophreniform psychosis, schizoaffective disorder, or related disorder.

If you are interested in participating, please email [email protected] or call Research Assistant Marko Milicevic at (03) 5227 2229 for more information.

We are also seeking referrals from clinicians who treat psychotic disorders in the Barwon region.

This study has ethical approval from Barwon Health Human Research Ethics Committee, HREC/79204/VICBH-2022-331357(v3).

 

BOOST-IC COVID-19 Vaccine Study

We are seeking participants for a study looking at COVID-19 booster vaccine responses in the following groups:

• People with HIV
• People who have received a solid organ transplant
• People with haematological malignancies— CLL, Myeloma, non‐Hodgkin Lymphoma

You may receive 1 or 2 doses of Moderna or Pfizer bivalent COVID-19 vaccine.

To find out more, please contact Anne Welsh on 4215 2879 or [email protected]

This research study has ethics approval from the Alfred.

 

New drug trial for Meth

We are studying whether mirtazapine can help people reduce their meth use.

Visit tinatrial.info for more information or contact Caity on 0432 236 786 or [email protected]

This trial has been approved by the University of Wollongong Human Research Ethics Committee
#2021/ETH12037

   

Victorian Cancer Trials

To view the cancer trials currently underway at Barwon Health, visit the Victorian Cancer Trials Link website.

Searching this website is easy. All you have to do is type information about you, your cancer or cancer treatment to begin. Once you have begun the search, you can narrow your results by selecting criteria on the left hand side of the page.

Once you have found a trial that you think you can join, speak to your doctor or contact the Barwon Health Cancer Services Trials Unit for more information.

 

New clinical trial to prevent Urinary Tract Infections (UTIs)

Barwon Health is currently looking for participants for a clinical trial to prevent Urinary tract infections (UTIs)

Participants would be required to attend several visits over a 3 year period.

You may be eligible if you are:

• Adults aged ≥ 60 years
• Have a history of UTI in the past 2 years
• In generally good health

For more information please call 03 4215 2877 or email [email protected]

This study has been approved by Monash Human Research Ethics Committee

 

Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) Study

This NHMRC study is a joint venture between Deakin University and Barwon Health that aims to improve the understanding of the disorder as well as to look for new treatments for ME/CFS. 

Who can participate?

• Individuals with a diagnosis of ME/CFS
• Individuals with no known disease (healthy controls)
• Male or female, 18-65 years old
• Not currently pregnant
• Not currently enrolled in a clinical trial

Key points for participants

• The study will not involve any costs
• Once enrolled in the study, you will receive a gift voucher up to $40 for any travel costs
• No additional treatment will be provided
• Surveys will be done online at your own pace
• Only ONE appointment needed to take part
• Study involves donating a blood sample

For more information

• https://redcap.link/chromicstudy
• 0352 273 804
• [email protected]

 

Weight loss study seeking night shift workers

Do you work at least four night shifts every fortnight, and want to lose weight?

We are seeking participants for a world-first study (SWIFt), which will compare different types of diets to help with weight loss & improve overall health for shift workers.

WHAT'S INVOLVED?

Over 18 months, you will:

• be given a dietary weight loss program to follow for 24 weeks
• consult with a dietitian regularly and be provided with study foods for 24 weeks
• after this period, be followed up for one year to monitor your progress
• have your body measurements taken throughout the study

HOW WILL I BENEFIT?

By volunteering for this study, you’re helping our researchers find a suitable diet plan that meets the needs of night shift workers.

The outcomes of SWIFt could result in new dietary recommendations that improve the health of night shift workers throughout Australia – and you’ll be playing a key role in helping us get there.

Participants will receive a $100 petrol voucher and be provided some study meals.

To find out more or to enrol now, please visit the SWIFt study website or scan the QR code

This study has been approved by Barwon Health Human Research Ethics Committee.

 

Whipple's Disease Study - healthy volunteers required

Whipple’s Disease is a rare but very serious infection which is due to a very common environmental bacterium. We suspect that many people are exposed to this bacterium but only very few become infected, for reasons not well understood. The bacterium is ingested with food and water and excreted in their faeces. Normal people produce antibodies to it.

We are asking healthy volunteers to:
1. Provide a saliva sample, as the mouth is the route of entry of this bacterium to the body.
2. Provide a faecal sample, as the bacterium is excreted from the body by this route. You will be given an empty container to place in your toilet and into which you will easily be able to collect some faeces. The container will come with a tightly fitting lid for safe transport to the lab.
3. Provide a blood sample, from which we will measure your level of antibodies to the bacterium.

For those who are interested to help out for this study, please contact Dr K.C Liew, Principal Investigator, on 0433 186 662 or [email protected]. Your time and effort for this study will be truly appreciated.

  

Cardiology Research Unit Trials

If you are intersted in finding out more about participating in any of our current trials, please contact us at (03) 4215 1033 or [email protected] 

SURMOUNT MMO Study

The purpose of this study is to determine if tirzepatide is better than placebo in reducing obesity related disease and death in adults living with obesity. Study visits occur every 4 weeks for the first 24 weeks, and every 12 weeks for the remainder of the study. You may be eligible to take part if you:

•  Have a BMI >27.0 kg/m2
• Are either:
  • individuals ≥40 years of age with established cardiovascular disease >90 days prior to Visit 1, or
  • women ≥55 years of age or men ≥50 years of age without established cardiovascular disease but have the presence of cardiovascular risk factors, such as current tobacco use, abnormal levels of fats (lipids) in the blood, high blood pressure, kidney disease, or elevated blood glucose levels.
• Are reliable and willing to make themselves available for the duration of the study, attend required study visits, and are willing and able to follow study procedures as required

 

OCEANIC AF Study

Atrial fibrillation is a condition where your heart beats in an abnormal way, and very quickly. It can make you more likely to have strokes or blood clots in the future. This disease is found much more often in people over the age of 60. Asundexian is a medicine that works to make your blood thinner. Thinning the blood can help prevent blood clots which can cause a stroke.

This study will assess the safety and efficacy of asundexian for the treatment of atrial fibrillation. The study is also being done to learn how asundexian moves into, through and out of the body.

 You may be eligible to take part if you:

• Are 18 + years of age
• Have been diagnosed with atrial fibrillation
• Are not currently taking blood thinners

 

HERMES Study

This study will assess the efficacy and safety of ziltivekimab for the treatment of people living with heart failure and inflammation. The study also aims to better understand heart failure and related diseases and how to improve treatment for these conditions.

You may be eligible to take part if you:

• Are 18 + years of age
• Have been diagnosed with heart failure and reduced kidney function

 

OCEAN(a) Outcome Study

Lipoprotein (a) (Lp(a)) has been shown to play a role in atherosclerosis. This study is being done to learn more about olpasiran (AMG 890) in people with cardiovascular disease and elevated Lp(a), in particular whether lowering Lp(a) by olpasiran (AMG 890) results in lower risk for adverse cardiovascular events

You may be eligible to take part if you:

• Are 18 + years of age
• Have been diagnosed with heart disease
• Have an elevated Lp(a) level

 

VICTORION PREVENT Study

The purpose of this research study is to determine if the study treatment, called inclisiran, taken in addition to statin medication in participants with established cardiovascular disease can safely and effectively lower the risk of cardiovascular events in the future (such as or including heart attacks, strokes, and cardiovascular-related deaths).

You may be eligible to take part if you:

• Are 18 + years of age
• Have been diagnosed with atherosclerotic disease:
• heart attack (also known as myocardial infarction);
• stroke; or
• peripheral artery disease (reduced circulation of blood to a body part other than the brain or heart)

 

EASY AS Study

Your heart valve condition (aortic stenosis, or AS) is a common condition in which one of the four heart valves narrows over many years. When a valve becomes narrow, it can reduce the flow of blood through the heart and the body. Symptoms can include shortness of breath and chest pain; these can take years to develop and some patients never develop symptoms at all.

Patients who do have symptoms can have the valve replaced. This works really well, but as with any medical procedure, there is a chance of complications, and it can take a long time to recover. Some heart specialists believe that replacing the valve before symptoms develop may be better than the more conventional approach of performing the AVR once symptoms develop.

You may be eligible to take part if you:

• Are 18 + years of age
• Have a diagnosis of severe aortic stenosis but no symptoms

 

ZEUS STUDY

We are doing the ZEUS study to see if ziltivekimab can be used to treat people with cardiovascular disease, chronic kidney disease and inflammation. A completed study showed that ziltivekimab can lower inflammation, which may have a positive effect on cardiovascular disease. The ZEUS study will see if ziltivekimab can reduce the risk of having cardiovascular events (for example heart attack and stroke).

You may be eligible to take part if you:

• Are 18 + years of age
• Have been diagnosed with blockages in your arteries – legs, heart or neck and reduced kidney function

 

GMRx2-HTN-2020-ACT1

High blood pressure is a cause of cardiovascular disease which includes heart attack and stroke. Therefore, managing high blood pressure is important in the prevention of cardiovascular disease. Most people with high blood pressure do not achieve adequate blood pressure control with just one medication. Some research suggests that low doses of three medications may be effective without increasing side-effects and use of a single pill can simplify therapy. 

This trial is evaluating a new medicine called GMRx2, which is a single pill combination containing active ingredients from three different blood pressure lowering medications called telmisartan, amlodipine and indapamide. GMRx2 has three dose versions, two of which contain lower doses of these active ingredients than are typically used together. All three of these medications have been given to large numbers of people over the last few decades and are already prescribed in many countries. These medications have been used either on their own or in combination with other blood pressure lowering medications.

You may be eligible to take part if you:

• Are 18 + years of age
• Have an elevated blood pressure reading

 

GMRx2-HTN-2020-PCT1

High blood pressure is a cause of cardiovascular disease which includes heart attack and stroke. Therefore, managing high blood pressure is important in the prevention of cardiovascular disease. Many people with high blood pressure require two or more different blood pressure lowering medications to achieve blood pressure control. However, the requirement for multiple medications can be expensive, makes it more difficult to adhere to treatment and increases the risk of side-effects.

GMRx2 is a single combination medication containing active ingredients from three different blood pressure lowering medications called telmisartan, amlodipine, and indapamide. All three of these medications are already prescribed in many countries to lower blood pressure and are used either on their own or with each other in dual combinations.

You may be eligible to take part if you:

• Are 18 + years of age
• Have an elevated blood pressure reading