Overview

Trial of Ondansetron as a Parkinson's HAllucinations Treatment

Status:
Not yet recruiting

Trial end date:
2023-04-01

Target enrollment:
0

Participant gender:
All

Summary

TOPHAT 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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University College, London

Collaborators:

Custom Pharmaceuticals Limited
MODEPHARMA Limited
PARKINSONS UK
PRIMENT
SEALED ENVELOPE
Wasdell Packaging Ltd

Treatments:

Ondansetron

Criteria

Inclusion Criteria:

1) Adults aged over 18 years. 2) Meet MDS criteria for Parkinson's disease. 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.

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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.

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