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

Phase 2

Conditions: Parkinson's hallucinations
Nervous System Diseases
Parkinson disease

Registration Number: ISRCTN51996779

Lead Sponsor: PRIMENT CT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Stopped

Sex: All

Target Recruitment: 168

Inclusion Criteria

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

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 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Hallucinations measured using SAPS-H (12 weeks)

Secondary Outcome Measures

Name	Time	Method
1. Visual hallucinations measured using SAPS-H (2, 4, 6, 12, 18, 24 weeks)<br>2. Delusions measured using SAPS-D (2, 4, 6, 12, 18, 24 weeks)<br>3. Global Severity (Impact) of symptoms measured using CGI-S (2, 4, 6, 12, 18, 24 weeks)<br>4. Hallucinations measured using UM-PDHQ (12 weeks)<br>5. Non-motor symptoms measured using NMSS (6, 12, 18, 24 weeks)<br>6. Proportion receiving quetiapine rescue medication at end of treatment (12 weeks) and follow-up (24 weeks) periods<br>7. Health-related quality of life measured using Euro-QoL, EQ-5D (6, 12, 18, 24 weeks) Parkinson’s symptoms (tremor, rigidity) UPDRS III (6, 12 weeks)<br>8. Cognition measured using sMMSE (12 weeks)<br>9. ECG changes measured using QTc interval (6 weeks)<br>10. Tolerability measured using adverse event checklist (2, 4, 6, 12, 18, 24 weeks)<br>11. Pharmacokinetics measured using Venous blood drug concentration (6, 12 weeks)<br>12. Visual information processing measured using HVOT (12 weeks)