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Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

NCT03325556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2021-06-21

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.

Conditions

  • Dementia-related Psychosis

Interventions

DRUG

Placebo

Placebo, tablets, once daily by mouth

DRUG

Pimavanserin 34 mg

Pimavanserin 34 mg total daily dose, tablets, once daily by mouth

DRUG

Pimavanserin 20 mg

Pimavanserin 20 mg total daily dose, tablets, once daily by mouth

Sponsors & Collaborators

  • ACADIA Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-27
Primary Completion
2019-07-31
Completion
2019-10-30
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Chile
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • Serbia
  • Slovakia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03325556 on ClinicalTrials.gov