Parkinson's Clinical Research
TOPHAT Study
Trial of Ondansetron for Hallucinations in Parkinson's
Study 2 TOPHAT Trial of Ondansetron as a Parkinsons HAllucinations Treatment_July29th.pptChief Investigator: Professor Suzanne Reeves, UCL, London
Recruiting Sites: Aneurin Bevan University Health Board (UHB); Betsi Cadwalladr UHB (Bangor and Wrexham); Cornwall Partnership NHS Foundation Trust (FT); Imperial College Healthcare NHS Trust; Lewisham and Greenwich NHS Trust; Luton and Dunstable Hospital FT; NHS Grampian; NHS Greater Glasgow & Clyde; NHS Tayside; UCLH-Leonard Wolfson Experimental Neurology Centre; Dartford and Gravesham; Salford Royal NHS Foundation Trust; Cambridge UH NHS FT; North West Anglia NHS FT; Barts Health NHS Trust; Northumbria Healthcare NHS FT; RBCH renamed to University Hospitals Dorset; University Hospitals of North Midlands-Royal Stoke ; The Newcastle upon Tyne Hospitals NHS FT; Oxford University Hospitals NHS FT; Barking, Havering and Redbridge UH NHS Trust; Sherwood Forest NHS; Pennine Acute NHS FT; Wrightington, Wigan and Leigh Teaching Hospitals NHS FT; Shrewsberry and Telford NHS; Royal United Hospitals Bath; Royal Devon and Exeter NHS FT; York and Scarborough NHS; Coventry and Warwickshire Partnership NHS Trust; The Walton Centre NHS FT; Southern Health NHS FT; Ashford and St Peter's Hospital; St. George's UH NHS FT' CTM-UHB (south Wales); East Suffolk and North Essex NHS FT; Lanarkshire; Belfast Health and Social Care Trust; St. Helen's and Knowsley Teaching Hospitals NHS Trust; Leeds and York NHS; University Hospitals Plymouth NHS Trust.
Timeframe: scheduled study recruitment end date is January 2025
UK Recruitment Target: 306
Link to further information: TOPHAT - University College London
Further Information
Study Goal:
Hallucinations are a symptom of Parkinson's that make it tricky to know what is real. Hallucinations are very common and sometimes very troublesome in Parkinson's, especially in older people and those who have had Parkinson's for a long time. There are only a few effective and safe treatments for people with Parkinson’s experiencing hallucinations. Finding safer options is a priority for patients, their families and doctors. This study aims to test a safe drug to see if it can help people with Parkinson's who have hallucinations.
What's Involved:
This trial tests whether a drug called ondansetron helps people with Parkinson's who are experiencing hallucinations. Ondansetron is a safe drug which is normally used to treat sickness after operations. Participants will either take ondansetron or a placebo (a "fake" sugar pill that looks identical but contains no drug). Study visits will take place at the start of the study and at 6 weeks, 12 weeks, 18 weeks and 24 weeks. The study team will measure any changes in hallucinations, delusions (false beliefs), Parkinson's symptoms (such as shaking, anxiety, sleep quality), memory and quality of life.
Who can take part?
People who:
Have a diagnosis of Parkinson’s
Are 18 years or older
Experience visual hallucinations at least every week
People can also have dementia; arrangements can be made if they are not able to make the decision about whether to take part themselves.
Interested Investigators:
To discuss becoming a participating site, contact: tophat@ucl.ac.uk or our coordinator Emma Fargher md4efa@sheffield.ac.uk
People with Parkinson's:
To discuss taking part in the study, contact: Olga Subko, o.zubko@ucl.ac.uk