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A common ingredient in cough syrup, ambroxol, is being tested as a treatment for Parkinson’s disease. Researchers led by a team at UCL will soon launch a Phase 3 clinical trial to assess the effectiveness of the drug in 330 people with the disease.
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“I am delighted to be leading this exciting project, ” said study lead Professor Anthony Schapira in a statement. “This will be the first time a drug specifically applied to a genetic cause of Parkinson’s disease has reached this level of trial and represents ten years of extensive and detailed work in the laboratory and in a proof of principle clinical trial.”
Ambroxol is a type of cough medicine known as an expectorant. It works by thinning down the sticky phlegm build-up caused by respiratory diseases such as bronchitis, making it easier for patients to clear their congestion by coughing. But a 2009 study planted the seed that could lead to a whole other use for this drug.
The study found that ambroxol increased the levels of an enzyme called glucocerebrosidase (GCase) in patients with a rare genetic disorder, Gaucher disease. People with this condition are also at higher risk of developing Parkinson’s disease, although scientists still don’t completely understand the connection.
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A typical feature of Parkinson’s disease is the accumulation of Lewy bodies – clusters of a protein called α-synuclein – in certain regions of the brain. When α-synuclein levels go up, GCase levels go down. So, when the 2009 paper showed that ambroxol was able to increase GCase levels in patients with Gaucher disease, researchers began to wonder if it might have the same effect in Parkinson’s disease, and – crucially – whether that might indirectly lower the levels of problematic α-synuclein.
A small human trial has already been performed by Professor Schapira’s team, and the results were encouraging. Ambroxol was able to get into the brain (no easy feat!), increasing the levels of GCase and possibly leading to more α-synuclein being cleared out, which would be great news for patients: “The increase in [cerebrospinal fluid] α-synuclein could be interpreted as an increase of extracellular export of the protein from the brain parenchyma, ” the researchers wrote in 2020.
Importantly, the drug was also found to be safe and well-tolerated by people with Parkinson’s disease, despite the fact that it was being given at much higher doses than are typically found in cough remedies. The next phase of the research is the larger-scale Phase 3 trial that has now been given the green light.
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The trial will take place across 10-12 clinical centers in the UK and will involve 330 people with Parkinson’s disease. They will be given ambroxol, or a placebo control, for a period of two years, during which their symptoms will be monitored to see if the treatment is able to slow the progression of the disease.
“Once the ambroxol trial is underway, it will be one of only six Phase 3 trials on public record of potentially disease-modifying drugs in Parkinson’s, worldwide, ” said Will Cook, CEO of charity Cure Parkinson’s, which is helping to fund the research.After finding that a drug found in cough syrups may have use as a treatment for Parkinson’s disease, researchers have received funding for the next stage in clinical trials.
Ambroxol, a medication originally designed to clear phlegm and ease coughing for people with respiratory diseases such as bronchitis, is being tested to see if it can slow down the progression of Parkinson’s disease by keeping cells healthier for longer.
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A research team led by Professor Tony Schapira ( Queen Square Institute of Neurology) reported in January that ambroxol was safe and well-tolerated in 17 study participants with Parkinson’s disease.
According to the findings published in JAMA Neurology, the drug also effectively crossed the blood-brain barrier and increased levels of the glucocerebrosidase (GCase) protein in the participants’ brain cells. This protein allows cells to remove waste more effectively, a function which evidence suggests is deficient in some people with Parkinson’s. Increasing levels of the protein may have the potential to keep cells healthier for longer and, therefore, slow Parkinson’s progression.
This week, The Cure Parkinson’s Trust (CPT), the Van Andel Institute (VAI) and the John Black Charitable Foundation announced £522, 126 of funding for the next stage of the research, which will seek to determine the optimal dosage of ambroxol. The trial will be run this year at the Leonard Wolfson Experimental Neurology Centre at and led by Professor Schapira, with the aim of leading to a larger clinical trial later on.
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“By increasing levels of GCase, ambroxol allows cells to remove waste, which would ideally keep cells healthier for longer and could slow down the progression of Parkinson’s, ” explained Professor Schapira.
The announcement comes as part of a USD $4.5 million co-funding agreement with the Van Andel Institute (VAI) to support the International Linked Clinical Trials (iLCT) initiative. iLCT is a thriving global programme that aims to develop new, potentially disease-modifying Parkinson’s therapies, many of which are repurposed medications originally designed or approved to treat other diseases.
Candidate drugs are evaluated and prioritised annually by a committee of world-leading Parkinson’s experts, who select which drugs should enter clinical trials in people with the condition. These drugs have the potential to get to the clinic much faster as they have already passed crucial safety tests.
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Professor Patrik Brundin, Chair of the Linked Clinical Trials committee and Director of the Center for Neurodegenerative Science at the VAI said: “We are thrilled to continue our long-standing collaboration with The Cure Parkinson’s Trust on the International Linked Clinical Trials initiative and look forward to expanding our program to evaluate additional promising medications in the coming years. We are especially grateful to the trial participants, without whom this critical work would not be possible.”
Will Cook, CEO of CPT said: “This will enable the launch of many more clinical trials of potentially disease-modifying repurposed and novel drugs that have been identified through the diligent iLCT process, and thereby bringing us closer to our goal: a cure for the 10 million people living with Parkinson’s globally.”Researchers believe Parkinson’s develops because of the breaking down or death of nerve cells in the substantia nigra, a part of the brain that controls movement.
Early in 2023, researchers will launch a phase 3 clinical trial of ambroxol, a cough medicine that is available over the counter in many countries, to study its ability to slow the progression of Parkinson’s disease.
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“It’s generally considered quite a safe drug, ” Dr. Anthony Schapira, head of the clinical neurosciences department at University College London Queen Square Institute of Neurology in the United Kingdom, and lead researcher on the phase 3 clinical trial, told
The trial is being undertaken in partnership with U.K. charity Cure Parkinson’s, the John Black Charitable Foundation, and the Van Andel Institute, a Michigan-based independent research facility.
It will follow 330 participants who have Parkinson’s at between 10 and 12 locations in the U.K. The study will take both Parkinson’s patients who have mutations in the
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“Our studies in the laboratory suggest that the drug may be beneficial not just to those with the mutation, but [it] may be also useful for those without the mutation, ” Dr. Schapira told MNT.
Dr. Michael Okun, national medical advisor for the Parkinson’s Foundation and chair of neurology and executive director at the Norman Fixel Institute for Neurological Diseases at the University of Florida Health, not involved in this research, explained for
“The reason that this study is of interest is the investigators are looking for something that may slow the disease progression in Parkinson’s, which is something that would be quite important and is something that’s missing from our armamentarium.”
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A 2009 study published in the Journal of Blood Chemistry reported that ambroxol increased levels of GCase in patients with Gaucher Disease.
A phase 2 clinical trial of ambroxol, also led by Dr. Schapira, followed 17 participants with Parkinson’s who received escalating daily doses of the cough medicine between January 11, 2017, and April 25, 2018. The mean age of participants was 60.2 years.
Over a 186-day period, participants received escalating doses of ambroxol beginning with 60 mg and increasing to 1.26 g daily. Participants received clinical visits and phone check-ins throughout the research period.
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Participants reported no adverse effects during the study. Researchers found the drug crossed the blood-brain barrier. Additionally, researchers discovered a 35% increase in levels of GCase in participants.
Dr. Schapira expects there to be considerable interest by individuals with Parkinson’s disease in participating in the phase 3 clinical trial. Individuals with Parkinson’s can sign up for the trials on Cure Parkinson’s website.
“I think our responsibility is to try and make sure we get all the patients needed as soon as possible and to get the trial completed as soon as possible, ” Dr. Schapira told MNT. “So that people with
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