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A clinical trial, sponsored by Gain Therapeutics, is investigating a potential new oral treatment for Parkinson’s disease. The investigational product has already been tested in healthy volunteers and found to be safe and generally well-tolerated. The current study is actively recruiting participants with Parkinson’s disease across several sites in Australia, and is now open for recruitment in Adelaide, Brisbane, Melbourne, and Sydney.
About the trial
The main goal of this Phase 1b clinical trial is to learn more about the safety and tolerability of the investigational product and to determine whether it has effects on certain biological parameters (also called biomarkers) that are believed to be involved in Parkinson’s.
The questions it aims to answer are:
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- What potential side effects may participants experience when taking the investigational product?
- How is the investigational product absorbed, distributed, and removed from the body of participants over time and how much of the drug gets into the bloodstream (pharmacokinetics)?
- Are there any biological effects of the investigational product in blood and in cerebrospinal fluid that could be beneficial for people with Parkinson’s disease?
Who can participate?
Potential participants must be 30-85 years of age and must have received a diagnosis of Parkinson’s within the last 7 years. There are other eligibility criteria that would be evaluated during the screening visit, including which medical conditions you may have, the results of laboratory tests, and what medications you are taking.
What to expect as a participant People taking part in the trial will:
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- Visit the clinic to assess if they qualify for the study (Screening Visit)
- Visit the clinic to take a sample of cerebrospinal fluid and undergo other baseline assessments
- Visit the clinic the first day of treatment, after the first 2 weeks of treatment, and every month during the 90-day Treatment Period
- Receive the investigational product to take at home once a day every day for 90 days
- Visit the clinic to assess how they are doing 14 days after the end of treatment (14- day Follow-Up Period).
To learn more about the eligibility criteria for the study, visit the ANZCT Registry website: ANZCTR – Registration.
Participating sites
Eligible participants can now enroll at the following active trial locations:
- CMAX: Phone – 1800 150 433 and email address: PET@cmax.com.au
- Alfred Health: NeurologyClinicaltrials@alfred.org.au or call +61 (0) 487 531 448
- Princess Alexandra Hospital: Schible Kurian (phone +61 436 447386; email schible.kurian@health.qld.gov.au)
- Southern Neurology: Elena Simon (phone: +61 408455183; email: elena.simon@southern-neurology.com.au)
– St Vincent’s Hospital Sydney: Umesh Tulachan email: umesh.tulachan@svha.org.au or Valerie Bramah (phone: + 61 2 8382 4977; email: valerie.bramah@svha.org.au)
Why participate?
By joining this clinical trial, participants will contribute to research aimed at finding new, effective treatments for Parkinson’s disease. This study may provide insights into how the investigational product interacts with the body and whether it may have beneficial effects on the condition. This is an important first step before conducting larger clinical trials to investigate whether the investigational product has effects on the clinical symptoms people with Parkinson’s disease experience.
How to get involved
If you or a loved one has Parkinson’s disease and is interested in participating, contact the site nearest to you. With trial sites active in Melbourne, Sydney, Brisbane, and Adelaide, now is an excellent time to explore this opportunity to contribute to Parkinson’s research.