A £5.5 million phase III trial is to begin in the UK this year, studying whether a cough medicine can help to slow down the progression of Parkinson’s disease.
Researchers at UCLH and UCL will lead the ASPro-PD study, a world-first phase III trial into the effectiveness of ambroxol, following promising results reported in a phase II trial in 2020.
The two-year placebo-controlled trial aims to sign up 330 people with Parkinson’s across 10-12 clinical centres in the UK.
Ambroxol is one of the drugs prioritised by the International Linked Clinical Trials (iLCT) programme, created and operated by Cure Parkinson’s and Van Andel Institute, which is helping to fund the study.
It is commonly used medication in Europe as a treatment for respiratory diseases as it promotes the clearance of mucus, eases coughing and has anti-inflammatory properties.
Results of the phase II clinical trial, which tested ambroxol in people with Parkinson’s and was published in *The Journal of the American Medical Association Neurology* in January 2020, showed that ambroxol effectively reached the brain and increased levels of GCase (glucocerebrosidase), which allows cells to remove waste proteins, including alpha-synuclein, more effectively.
Study lead Professor Anthony Schapira, of UCL Queen Square Institute of Neurology, UCLH and the Royal Free London NHS Hospital Trust, said: “I am delighted to be leading this exciting project. This will be the first time a drug specifically applied to a cause of Parkinson’s disease has reached this level of trial and represents 10 years of extensive and detailed work in the laboratory and in a proof of principle clinical trial.”
Will Cook, CEO of Cure Parkinson’s, added: “This trial is a big step forward in the search to find new treatments for Parkinson’s. Once the ambroxol trial is underway, it will be one of only six phase III trials on public record of potentially disease-modifying drugs in Parkinson’s, worldwide.”
The research team is still recruiting participants for the study PD Frontline.
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