To evaluate the safety and tolerability of LBT-3627, The Alfred in Melbourne, Victoria is looking for 24 people with early-stage Parkinson’s to participate in an innovative Phase 1 clinical trial.
This trial will explore how this potential Parkinson’s medication acts in the body at different doses as it aims to ‘rebalance’ the immune system, which could ultimately wind up being disease modifying.
This study has been approved by a Human Research Ethics Committee and will be conducted with medical oversight by the Alfred Neurology Clinic.
Who can participate in this trial?
To take part in this trial, you must:
- Have been diagnosed by a neurologist or geriatrician with Parkinson’s for between 1 - 10 years
- Be either not taking Parkinson’s medications or be on a stable dose of levodopa for at least 2 months
- Be in generally good health
- Be prepared to attend The Alfred (Melbourne, Victoria) for the required 14 consecutive daily visits, including an overnight stay for 3 nights – some visits will be in the ‘Off’ state.
If any of the below applies to you, you will not be able to participate in this trial:
- Currently pregnant or breastfeeding
- Previous deep brain stimulation (DBS) surgery
- Ongoing infrared light therapy
- Diagnosis of dementia
- Smoking more than one pack per week
- Regular use of cannabis or cannabidiol products
- Diagnosis of cancer within the last 5 years.
Please note: Neither of these inclusion and exclusion criteria lists are exhaustive and there may be additional prerequisites required by the medical team.
What will I be asked to do during this trial?
If deemed eligible, you will receive the trial medication, LBT-3627, once a day, in the mornings, for 14 days. You will also be required to attend 2 weekly follow-up appointments. The maximum participation time is 28 days.
For the first 3 days of the study, you will be required to stay overnight at The Alfred in Victoria. You will undergo multiple assessments during this time, including a Parkinson’s specific exam, blood and urine testing.
The remainder of the study is conducted in an outpatient setting, also at The Alfred.
Where is The Alfred?
The Alfred is situated at:
55 Commercial Road
Melbourne, Victoria
3004
Click here to view The Alfred on Google Maps.
Why should I participate in this trial?
People who live with Parkinson’s have traditionally managed their symptoms with various forms of Dopamine. However, there are no approved Parkinson’s modifying treatments yet.
The development of new therapeutic approaches requires clinical trials like this one, to evaluate their performance.
Your participation in this study will help move the field forward by evaluating the safety and tolerability of LBT-3627.
Clinical trials like this are essential in unlocking the medical breakthroughs that could change the lives of more than 219,000 Australians living with Parkinson’s today, and all those diagnosed in the future.
Important notes:
- Participants will be required to stay overnight at The Alfred for the first 3 days of the study
- In order to evaluate the therapeutic potential of LBT-3627, most of the clinical assessments must be conducted in the ‘Off’ state
- All enrolled participants will be paid for their participation.
Interested in taking part?
If you meet the above criteria and would like to learn more, please reach out to the clinical trial coordinators at The Alfred for a copy of the patient information and consent form.
The team will try to respond to any interest in the trial within 48 hours of receiving your call or email.
Call: +61 487 531 448 (Available Mon – Fri, 9:00 AM – 4:00 PM)
Email: [email protected] - Please include your full name and contact number in any written communication.
