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Research type
Research Study
Full title
Trial of Ondansetron as a Parkinson’s HAllucinations Treatment
IRAS ID
266504
Contact name
Suzanne Reeves
Contact email
Sponsor organisation
University College London
Eudract number
2019-003962-41
Duration of Study in the UK
3 years, 2 months, 14 days
Research summary
Hallucinations, the most common and distressing feature of Parkinson's psychosis, are associated with poor quality of life and earlier care home placement. Treatment options are limited and associated with significant harm, as they can worsen Parkinson’s symptoms and increase the risk of death. Finding safer alternatives is a priority for patients, their families and prescribing clinicians.
This study investigates whether ondansetron, a drug used to treat post-operative sickness, will have a meaningful treatment effect on Parkinson's hallucinations and will be safe and cost effective for NHS use. Adults with Parkinson's who are aged over 18 years will be eligible to take part if they are experiencing visual hallucinations at least weekly. They may or may not have a diagnosis of dementia and, for those who capacity to give fully informed consent, a legal representative will be sought to give consent on their behalf.
We will compare ondansetron to placebo (a tablet that looks identical but contains no drug) after 6 and 12 weeks treatment, with follow up at 18 and 24 weeks. We will also investigate side effects, treatment effects on hallucinations, delusions (false beliefs), Parkinson's symptoms (tremor, anxiety, sleep disturbance), memory and quality of life. Blood samples will be taken during the 6 and 12 weeks assessments, to measure blood drug concentration. This will tell us how quickly the drug is cleared from the body, and how this relates to treatment effects and side-effects, to guide future prescribing. Based on previous Parkinson’s treatment studies, we will need to recruit 216 people to detect differences between ondansetron and placebo treated groups. Recruitment will take place in the UK over 2 years, in 20-25 UK-based NHS clinics led by neurologists, psychiatrists, and geriatricians, with follow up and analysis, publication and dissemination of results being completed at 4 years.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0377
Date of REC Opinion
3 Feb 2020
REC opinion
Further Information Favourable Opinion