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Trial of Ondansetron as a Parkinson's HAllucinations Treatment

NCT04167813 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2024-03-27

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson's Hallucinations
  • Dementia With Lewy Bodies

Interventions

DRUG

Ondansetron 8mg or matched placebo tablets

Participants will take one tablet daily in weeks 1 and 2, two tablets daily in weeks 3 and 4 and 3 tablets daily in weeks 5 and 6. Dose escalation will be guided by tolerability, through telephone safety monitoring prior to each dose increase

Sponsors & Collaborators

  • MODEPHARMA Limited

    collaborator UNKNOWN

  • Parkinson's UK

    collaborator OTHER

  • PRIMENT

    collaborator UNKNOWN

  • SEALED ENVELOPE

    collaborator UNKNOWN

  • Wasdell Packaging Ltd

    collaborator UNKNOWN

  • Custom Pharmaceuticals Limited

    collaborator UNKNOWN

  • University College, London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-08-30
Completion
2024-08-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04167813 on ClinicalTrials.gov