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Efficacy, Safety and Pharmacokinetics Study of CPL500036 (PDE10A Inhibitor) in Patients With Schizophrenia

NCT05278156 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2025-09-10

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy, safety, tolerability and pharmacokinetics (PK) properties of CPL500036 compound (PDE10a inhibitor) in patients with an acute exacerbation of schizophrenia after 28 days of administration..

Conditions

Interventions

DRUG

CPL500036 - low dose

CPL500036 is to be oral administered. Each patient is to take 2 capsules with active substance and 2 capsules of placebo daily.

DRUG

CPL500036 - high dose

CPL500036 is to be oral administered. Each patient is to take 4 capsules with active substance daily.

DRUG

Placebo

Placebo is to be oral administered. Each patient is to take 4 capsules of placebo daily.

Sponsors & Collaborators

  • National Center for Research and Development, Poland

    collaborator OTHER

  • Celon Pharma SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2024-06-05
Completion
2024-06-19

Countries

  • Hungary
  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05278156 on ClinicalTrials.gov