Trial of Ondansetron as a Parkinson’s HAllucinations Treatment

PRIMENT CT0 个研究点目标入组 168 人开始时间: 2020年2月5日最近更新: 2024年4月22日

适应症

试验速览

暂无简介。

•1. Aged over 55 years
•2. Meet Brain Bank criteria for Parkinson’s disease
•3. Visual hallucinations have been present at least weekly in the month before screening and are moderately severe
•4. On a stable dose of anti-Parkinson’s medication, cholinesterase inhibitor or memantine for at least 28 days
•5. Capacity to give informed consent or (if lacking) caregiver or other legal representative able to give consent
•6. Pre-menopausal women, and men whose partners are of child bearing potential who agree to use effective contraception during the trial treatment period

•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 any antipsychotic medication in the past 2 weeks
•5. Prescribed apomorphine
•6. Prescribed tropisetron, granisetron, dolasetron
•7. History of hypersensitivity to ondansetron and its excipients (or those of placebo) or drugs listed in 6
•8. Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days

发起方

PRIMENT CT