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

NCT05278156 | Completed Phase 2

• 1 other identifier: 02PDE2019
• Study Type: interventional
• Target: 189
• Locations: 3 countries
• Sites: 16

Brief 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

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in PANSS positive subscale at Day 28.

  The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient.Total score is 210 points. The higher PANSS total score, the more severe schizophrenia.

  Day -1, Day 28

Secondary Outcomes (21)

• Change from baseline in PANSS positive subscale at Week 1, 2 and 3

  Day -1, Week 1, 2 and 3

• Change from baseline in PANSS Total Score at Weeks 1, 2, 3, 4

  Day -1, Week 1, 2, 3 and 4

• Change from Baseline in PANSS Subscales Using the Marder 5 factor Model at Weeks 1, 2, 3, and 4

  Day -1, Week 1, 2, 3 and 4

• Change from Baseline in PANSS Negative Subscales at Weeks 1, 2, 3 and 4

  Day -1, Week 1, 2, 3 and 4

• Change from Baseline in PANSS general psychopathology Subscale at Weeks 1, 2, 3 and 4

  Day -1, Week 1, 2, 3 and 4

Study Arms (3)

CPL500036 low dose

EXPERIMENTAL

Patients are to receive 20 mg of CPL500036 administered once dail for 28-days treatment period.

Drug: CPL500036 - low dose

CPL500036 high dose

EXPERIMENTAL

Patients are to receive 40 mg of CPL500036 administered once dail for 28-days treatment period.

Drug: CPL500036 - high dose

Placebo

PLACEBO COMPARATOR

Patients are to receive placebo administered once dail for 28-days treatment period.

Drug: Placebo

Interventions

CPL500036 - low dose DRUG

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

CPL500036 low dose

CPL500036 - high dose DRUG

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

CPL500036 high dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has a primary diagnosis of schizophrenia confirmed by clinical interview \[SCID-5-CT\].
• Male or female patient aged 18 to 65, inclusive, at Screening.
• The patient's with exacerbation of psychotic symptoms
• The patient has a score of 5 or higher in 3 or more items of the following PANSS items at Screening and Baseline
• The patient has a PANSS Total Score of 80 or higher during Screening and on Baseline
• The patient of childbearing potential willing to use acceptable forms of contraception.
• The patient has a score in CGI-S scale of 4 or greater at Screening and on Baseline
• The patient is able to and agrees to remain off prior antipsychotic medication and all excluded medications as outlined in the protocol for the duration of the Treatment Period.
• The patient is able to sign informed consent after receiving information about the trial and has the ability and willingness to comply with the requirements and restrictions of the study protocol.

You may not qualify if:

• The patient has a decrease in the PANSS Total Score at Baseline compared with the Total Score at Screening.
• Patient who recently participated in another interventional clinical study with an Investigational Medicinal Product.
• The patient has uncontrolled abnormality which may impact the ability of the patient to participate or potentially confound the study results.
• The patient has a history of severe head injury, traumatic brain injury, myocardial infarction or stroke.
• The patient has a moderate or severe substance use disorder for alcohol or other substances of abuse except nicotine or caffeine.
• The patient is pregnant or lactating or intending to become pregnant or intending to donate ova.
• The patient has a history of or known personality disorder or other psychiatric disorder that, in the opinion of the Investigator, would interfere with participation in the study.
• The patient is considered by the Investigator to be at imminent risk of suicide or injury to self or others.
• The patient has chronic movement disorder that may interfere with the interpretation of study results.
• The patient has any existing or previous history of cancer or has newly diagnosed diabetes.
• The patient has long QT syndrome or is under treatment with antiarrhythmic drugs.
• The patient is considered to be treatment resistant. .
• The patient has received electroconvulsive therapy.
• The patient has any laboratory values outside the normal range that are considered by the Investigator to be clinically significant at Screening.

Sponsors & Collaborators

• Celon Pharma SA: lead
• National Center for Research and Development, Poland: collaborator

Study Sites (16)

Department of Psychiatry and Psychotheraapy of Semmelweis University

Budapest, H-1083, Hungary

Location

Semmelweis University, Faculty of Medicine, Department of Psychiatry and Psychotherapy

Budapest, H-1085, Hungary

Location

Department of Psychiatry, Mental hygiene and Addictology of Petz Aladár County Teaching Hospital

Győr, H-9024, Hungary

Location

Bács-Kiskun County Teaching Hospital Kalocsa Holy Cross Hospital

Kalocsa, H-6300, Hungary

Location

Psychiatry Department of Tolna County Balassa Janos Hospital

Szekszárd, H-7100, Hungary

Location

Uniwersytecki Szpital Kliniczny

Bialystok, 15-272, Poland

Location

Wojewódzki Szpital dla Nerwowo i Psychicznie Chorych

Bolesławiec, 59-700, Poland

Location

Samodzielny Publiczny Psychiatryczny Zakład Opieki Zdrowotnej

Choroszcz, 16-070, Poland

Location

Wojewódzki Szpital dla Psychicznie i Nerwowo Chorych

Gmina Świecie, 86-100, Poland

Location

Ivano-Frankivsk National Medical University, Department of Psychiatry, Narcology and Medical Psychology

Ivano-Frankivsk, 76014, Ukraine

Location

Communal non-profit enterprise "Clinical Hospital "PSYCHIATRY"" of the executive body of the Kyiv City Council (Kyiv City State Administration), Center for Primary Psychotic Episode and Modern Treatment Methods.

Kyiv, 04080, Ukraine

Location

Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association", women's department No. 2, men's department No. 10.

Kyiv, 08631, Ukraine

Location

Communal non-commercial enterprise of the Lviv Regional Council "Lviv Regional Clinical Psychoneurological Dispensary",

Lviv, 79017, Ukraine

Location

Communal non- commercial enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital",

Lviv, 79021, Ukraine

Location

Ternopil National Medical University named after I.Y. Gorbachevskiy of the Ministry of Health of Ukraine, Department of Psychiatry, Narcology and Medical Psychology

Ternopil, 46001, Ukraine

Location

Vinnytsia National Medical University named after M.I. Pirogov, Department of Psychiatry, Narcology and Psychotherapy with a course of postgraduate education

Vinnytsia, 21018, Ukraine

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 14, 2022
• Study Start: May 19, 2021
• Primary Completion: June 5, 2024
• Study Completion: June 19, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

HU (5); UA (7); PL (4)