The world’s largest-ever clinical trial of treatments to slow or stop the progression of Parkinson’s disease has launched, led by researchers at UCL and Newcastle University.
The £26 million project is accelerating the search for effective treatments with an innovative, flexible trial design testing multiple treatments in parallel. By testing more drugs more efficiently than ever before, the trial could take up to three years off the time needed to test a drug candidate.
The trial team is recruiting up to 1,600 participants in its first phase from more than 40 hospitals across the UK. People with Parkinson’s can register their interest in participating using a simple online form.
Parkinson’s disease is one of the world’s fastest growing neurological conditions, with 166,000 people affected in the UK today. Parkinson’s gets progressively worse and although there are treatments that can help with symptoms, these become less effective over time, so there is an urgent need to find treatments that can slow or stop the disease progression.
The Edmond J Safra Accelerating Clinical Trials in Parkinson’s Disease (EJS ACT-PD) trial is sponsored by UCL and funded by a Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership, Cure Parkinson’s, The Michael J Fox Foundation, Parkinson’s UK, The John Black Charitable Foundation, The Gatsby Charitable Foundation and Van Andel Institute.
The BRC at UCLH supports the movement disorders centre which was awarded the original EJS grant to set up the trial, and the BRC supports the ongoing trial initiative. Participants are being recruited at the NIHR UCLH Clinical Research Facility site, located within the National Hospital for Neurology and Neurosurgery.
Co-chief investigator Professor Thomas Foltynie (UCL Queen Square Institute of Neurology) said: “Parkinson's disease is the second most common neurodegenerative disease worldwide, and yet there are no treatments that can slow its relentless progression. We are prioritising drugs that already show promise as potential treatments, based on an extensive review of prior evidence, as we seek to identify a drug that does more than just provide symptom relief for Parkinson’s. We hope this trial will serve as a blueprint for future trials in Parkinson’s and other neurodegenerative conditions.”
Initially, the trial will be testing two drugs known to be safe and effective at treating other conditions: a blood pressure medication and a drug used to treat an enlarged prostate.
The first participant to be recruited into the trial, Graham Edwins, said: “I wanted to be part of EJS ACT-PD because of the pioneering approach to test multiple medications in a single trial. Having Parkinson’s, especially young onset, your choices are denial, acceptance or to fight back, which is what I feel I am doing by taking part. Even if I don’t directly benefit, if I can help progress a potential treatment or cure for the next person diagnosed in their prime then it’s a job well done.”
By analysing results on an ongoing basis, ineffective treatments can be identified and dropped from the trial, with more promising drugs progressing. The design’s flexibility also allows new treatment arms to be introduced within the same trial infrastructure.
The current standard clinical trials process is hugely time and resource consuming and stop-start in nature, taking up to 10 years for a single potential treatment to complete assessment. Compared to running individual trials for each treatment, the structure of the EJS ACT-PD trial can accelerate the assessment process by close to 25% (or up to three years).
Professor Sonia Gandhi (UCL Queen Square Institute of Neurology and The Francis Crick Institute), who is co-leading the EJS ACT-PD trial innovation programme said: “This research will tell us which drugs might be effective, but critically why and how a drug may be working, and who may respond to it – it will change the way we monitor Parkinson’s in future trials.”
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