Trial of Ondansetron as a Parkinson's HAllucinations Treatment: TOP HAT

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 216

Inclusion Criteria

1) Adults aged over 18 years
2) Meet Movement Disorder Society criteria for Parkinson’s disease
3) Score of 3 or more on the Scale for Assessment of Positive Symptoms- Hallucinations (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 (hormonal or barrier method of birth control; true abstinence) from the time consent is signed until 6 weeks after treatment discontinuation and inform the trial team if pregnancy occurs. For the purpose of clarity, true abstinence is when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence, withdrawal, spermicides only or lactational amenorrhoea method for the duration of a trial, are not acceptable methods of contraception).
9) Females of childbearing potential have a negative urine pregnancy test within 7 days prior to being registered/randomised. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
10) 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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 76
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

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. 5) Prescribed tropisetron, granisetron, dolasetron. 6) History of hypersensitivity to ondansetron and its excipients (or those of placebo) or drugs listed in 5). 7)Clinically significant co-morbidity, which in the opinion of the PI would prevent safe participation in this study. 8) Unable or unwilling to comply with study procedures. 9) Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

A clinical trial to explore the potential of ondansetron for treating hallucinations in people with Parkinson’s disease

Phase 2

PRIMENT CT

Updated 4/22/2024