Dementia With Lewy Bodies Clinical Trial
— TOP HATOfficial title:
Trial of Ondansetron as a Parkinson's HAllucinations Treatment
Verified date | March 2024 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
TOPHAT (Trial of Ondansetron as a Parkinson's HAllucinations Treatment) is a double blind, individually randomized, placebo-controlled, parallel group, flexible dose trial of ondansetron (8-24mg/day) as a treatment for Parkinson's hallucinations, with a 12-week primary outcome and follow-up to 24 weeks.
Status | Active, not recruiting |
Enrollment | 168 |
Est. completion date | August 30, 2024 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adults aged over 18 years. 2. Meet MDS criteria for Parkinson's disease or revised criteria for DLB. 3. Score of 3 or more on the SAPS-H visual hallucinations item, indicating the presence of visual hallucinations at least weekly in the previous month. 4. Score of 3 or more on SAPS-H global rating, indicating moderate symptom severity. 5. Score of 4 or more on CGI-S, indicating moderate symptom severity. 6. On a stable dose of anti-Parkinson's medication, cholinesterase inhibitor or memantine for at least 28 days. 7. Capacity to give informed consent or, if lacking, legal representative able to give consent. 8. Pre-menopausal women, and men whose partners are of child bearing potential will agree to use effective contraception. 9) If treated with an antipsychotic drug at the time of enrolment, can still participate, provided the drug is stopped the day before trial medication is commenced. - Exclusion Criteria: 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 apomorphine (if apomorphine is discontinued, rescreen once stable on an alternative anti-Parkinson's treatment). 5. Prescribed tropisetron, granisetron, dolasetron. 6. History of hypersensitivity to ondansetron and its excipients (or those of placebo) or drugs listed in 5). 7. Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days. - |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Grampian | Aberdeen | |
United Kingdom | Betsi Cadwaladr | Bangor | |
United Kingdom | Pennine | Bury | |
United Kingdom | Addenbrookes | Cambridge | |
United Kingdom | Dartford | Dartford | |
United Kingdom | Tayside | Dundee | |
United Kingdom | Glasgow | Glasgow | |
United Kingdom | Barking | London | |
United Kingdom | Bart's Health | London | |
United Kingdom | Imperial College NHS | London | |
United Kingdom | Lewisham | London | |
United Kingdom | Luton & Dunstable | London | |
United Kingdom | UCLH NHS foundation trust | London | |
United Kingdom | Newcstle | Newcastle | |
United Kingdom | Anuerin Bevan | Newport | |
United Kingdom | Northumbria | North Shields | |
United Kingdom | Oxford | Oxford | |
United Kingdom | North West Anglia | Peterborough | |
United Kingdom | Dorset | Poole | |
United Kingdom | Cornwall | Redruth | |
United Kingdom | Salford | Salford | |
United Kingdom | North Midlands | Stoke | |
United Kingdom | Sherwood Forest | Sutton In Ashfield |
Lead Sponsor | Collaborator |
---|---|
University College, London | Custom Pharmaceuticals Limited, MODEPHARMA Limited, PARKINSONS UK, PRIMENT, SEALED ENVELOPE, Wasdell Packaging Ltd |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hallucinations | Scale for Assessment of Positive Symptoms-Hallucinations (0-35 points, higher scores indicate greater severity of hallucinations | 12 weeks | |
Secondary | Delusions | Scale for Assessment of Positive Symptoms-Delusions (0-65 points, higher scores indicate greater symptom severity | 2, 4, 6, 12, 18, 24 weeks | |
Secondary | Safety and tolerability | Number of Participants With Treatment-Related Adverse Events | 2, 4, 6, 12, 18, 24 weeks | |
Secondary | Health related quality of life | EQ-5D-5L | 6, 12, 18, 24 weeks | |
Secondary | Cost effectiveness | Health and social service utilisation | 2, 4, 6, 12, 18, 24 weeks | |
Secondary | Pharmacokinetics, plasma concentrations of the study drug | Measured using a validated HPLC/MS assay | 6, 12 weeks | |
Secondary | Hallucinations | Scale for Assessment of Positive Symptoms-Hallucinations (0-35 points, higher scores indicate greater severity of hallucinations | 2, 4, 6, 18, 24 weeks | |
Secondary | Global illness severity | Clinical Global Impression of Severity Scale (1-7, higher scores indicate greater severity) | 2, 4, 6, 12, 18, 24 weeks | |
Secondary | Non-motor symptoms | Non-motor symptoms scale (0-120, higher scores indicate greater severity | 2,4,6,12,18,24 weeks | |
Secondary | Cognition | Standardised Mini-Mental State Examination (0-30, higher scores indicate better performance) | 12 weeks | |
Secondary | Hallucinations | University of Miami Parkinson's disease Hallucinations Questionnaire (0-15, where higher scores indicate greater symptom severity) | 6, 12 weeks | |
Secondary | Feasibility and Acceptability of Video Consultation | The feasibility of video consultation will be measured at baseline, 6 and 12 weeks by the proportion of participants who were able to successfully attend on at least one occasion, the proportion who successfully attended all three assessments, and a Satisfaction questionnaire that allows both quantitative and qualitative information to be collected. | baseline, 6 and 12 weeks |
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