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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Parkinson's hallucinations
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Visual hallucinations (seeing things that do not exist) occur in 75% of people with Parkinson’s across the illness course, are often highly distressing, have a significant impact on quality of life, and are associated with dementia and earlier care home placement. NHS treatment options are currently limited to medications known as antipsychotics that are associated with significant side-effects, including sedation, falls, worsening of Parkinson’s symptoms (tremor, movement co-ordination) and memory problems. Usual treatment involves quetiapine, as it is safer than other antipsychotic drugs, but of questionable effectiveness, or clozapine, which is effective but not feasible for use outside specialist units due to safety monitoring requirements. Pimavanserin, is a newly developed drug that has shown modest treatment effects, but is highly expensive, and not licensed for use in the UK. Findings treatments that are safe, effective, cost effective and practical for use in NHS clinics is a priority. Ondansetron, a drug used to treat post-operative nausea and vomiting, was identified as a highly promising candidate treatment for Parkinson’s hallucinations in the early 1990s, when 16 people with Parkinson's and persistent severe visual hallucinations improved with ondansetron (12-24mg daily), 14 with complete resolution of symptoms, with no worsening of Parkinson’s symptoms, memory or functional ability. Further studies were not carried out at the time because the drug was then extremely expensive. Costs are now much less (equivalent to usual treatment) and a larger trial in people with Parkinson’s is feasible, timely and highly necessary
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Bradycardia (<50 bpm) (rescreen if reversible)2. Congenital long QTc syndrome or presence of clinically significant prolongation of QTc (>460 ms for men or >470 ms for women) on ECG screening.3. Severe hepatic failure (bilirubin >50 micromole/L)4. Prescribed any antipsychotic medication in the past 2 weeks5. Prescribed apomorphine6. Prescribed tropisetron, granisetron, dolasetron7. History of hypersensitivity to ondansetron and its excipients (or those of placebo) or drugs listed in 68. Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Olga
Zubko
+44 (0)20 3545 9073
o.zubko@ucl.ac.uk
The study is sponsored by PRIMENT CTU and funded by Parkinson's UK.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 44305
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