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

Last updated: September 3, 2025
Sponsor: Celon Pharma SA
Overall Status: Completed

Phase

2

Condition

Schizotypal Personality Disorder (Spd)

Tourette's Syndrome

Psychosis

Treatment

CPL500036 - low dose

CPL500036 - high dose

Placebo

Clinical Study ID

NCT05278156
02PDE2019
  • Ages 18-65
  • All Genders

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..

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patient has a primary diagnosis of schizophrenia confirmed by clinical interview [SCID-5-CT].

  2. Male or female patient aged 18 to 65, inclusive, at Screening.

  3. The patient's with exacerbation of psychotic symptoms

  4. The patient has a score of 5 or higher in 3 or more items of the following PANSSitems at Screening and Baseline

  5. The patient has a PANSS Total Score of 80 or higher during Screening and on Baseline

  6. The patient of childbearing potential willing to use acceptable forms ofcontraception.

  7. The patient has a score in CGI-S scale of 4 or greater at Screening and on Baseline

  8. The patient is able to and agrees to remain off prior antipsychotic medication andall excluded medications as outlined in the protocol for the duration of theTreatment Period.

  9. The patient is able to sign informed consent after receiving information about thetrial and has the ability and willingness to comply with the requirements andrestrictions of the study protocol.

Exclusion

Exclusion Criteria:

  1. The patient has a decrease in the PANSS Total Score at Baseline compared with theTotal Score at Screening.

  2. Patient who recently participated in another interventional clinical study with anInvestigational Medicinal Product.

  3. The patient has uncontrolled abnormality which may impact the ability of the patientto participate or potentially confound the study results.

  4. The patient has a history of severe head injury, traumatic brain injury, myocardialinfarction or stroke.

  5. The patient has a moderate or severe substance use disorder for alcohol or othersubstances of abuse except nicotine or caffeine.

  6. The patient is pregnant or lactating or intending to become pregnant or intending todonate ova.

  7. The patient has a history of or known personality disorder or other psychiatricdisorder that, in the opinion of the Investigator, would interfere withparticipation in the study.

  8. The patient is considered by the Investigator to be at imminent risk of suicide orinjury to self or others.

  9. The patient has chronic movement disorder that may interfere with the interpretationof study results.

  10. The patient has any existing or previous history of cancer or has newly diagnoseddiabetes.

  11. The patient has long QT syndrome or is under treatment with antiarrhythmic drugs.

  12. The patient is considered to be treatment resistant. .

  13. The patient has received electroconvulsive therapy.

  14. The patient has any laboratory values outside the normal range that are consideredby the Investigator to be clinically significant at Screening.

Study Design

Total Participants: 189
Treatment Group(s): 3
Primary Treatment: CPL500036 - low dose
Phase: 2
Study Start date:
May 19, 2021
Estimated Completion Date:
June 19, 2024

Study Description

This is a double-blind, randomized, placebo controlled, parallel group, dose ranging study to explore the efficacy, safety, tolerability and PK of 2 different doses of CPL500036 (phosphodiesterase 10A [PDE10A] inhibitor) in patients with an acute exacerbation of schizophrenia. Approximately 165 patients will be randomized at a 1:1:1 ratio and will be dosed with 20 mg CPL500036, 40 mg CPL500036 or placebo once daily for 28 consecutive days (Day 1 to Day 28). Patients will remain in house for the duration of the Treatment Period. The study will comprise of a Screening Period (that will include a prior Medication Washout Period), a Treatment Period and a Follow-up Period. After discharge from the Clinical Unit, patients will return to the Clinical Unit for 2 once weekly Follow-up Visits. Approximately 30% of the patients (17 patients in each of the 3 treatment groups) will undergo extensive PK sampling during the Treatment Period, and the remaining 70% of the patients will only undergo sparse PK sampling.

Connect with a study center

  • Department of Psychiatry and Psychotheraapy of Semmelweis University

    Budapest, H-1083
    Hungary

    Site Not Available

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

    Budapest, H-1085
    Hungary

    Site Not Available

  • Department of Psychiatry and Psychotheraapy of Semmelweis University

    Budapest 3054643, H-1083
    Hungary

    Site Not Available

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

    Budapest 3054643, H-1085
    Hungary

    Site Not Available

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

    Győr, H-9024
    Hungary

    Site Not Available

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

    Győr 3052009, H-9024
    Hungary

    Site Not Available

  • Bács-Kiskun County Teaching Hospital Kalocsa Holy Cross Hospital

    Kalocsa, H-6300
    Hungary

    Site Not Available

  • Bács-Kiskun County Teaching Hospital Kalocsa Holy Cross Hospital

    Kalocsa 3050719, H-6300
    Hungary

    Site Not Available

  • Psychiatry Department of Tolna County Balassa Janos Hospital

    Szekszárd, H-7100
    Hungary

    Site Not Available

  • Psychiatry Department of Tolna County Balassa Janos Hospital

    Szekszárd 3044760, H-7100
    Hungary

    Site Not Available

  • Uniwersytecki Szpital Kliniczny

    Bialystok 776069, 15-272
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny

    Białystok, 15-272
    Poland

    Site Not Available

  • Szpital dla Nerwowo i Psychicznie Chorych

    Bolesławiec, 59-700
    Poland

    Active - Recruiting

  • Wojewódzki Szpital dla Nerwowo i Psychicznie Chorych

    Bolesławiec, 59-700
    Poland

    Site Not Available

  • Wojewódzki Szpital dla Nerwowo i Psychicznie Chorych

    Bolesławiec 3102987, 59-700
    Poland

    Site Not Available

  • Samodzielny Publiczny Psychiatryczny Zakład Opieki Zdrowotnej

    Choroszcz, 16-070
    Poland

    Site Not Available

  • Samodzielny Publiczny Psychiatryczny Zakład Opieki Zdrowotnej

    Choroszcz 774393, 16-070
    Poland

    Site Not Available

  • Wojewódzki Szpital dla Psychicznie i Nerwowo Chorych

    Gmina Świecie 3084074, 86-100
    Poland

    Site Not Available

  • Szpital Neuropsychiatryczny, Samodzielny Publiczny Zakład Opieki Zdrowotnej

    Lublin, 20-442
    Poland

    Site Not Available

  • Klinika Psychiatrii Dorosłych Uniwersytetu Medycznego w Poznaniu

    Poznań, 60-572
    Poland

    Site Not Available

  • Specjalistyczny Psychiatryczny Zespół Opieki Zdrowotnej

    Łódź, 91-229
    Poland

    Site Not Available

  • Wojewódzki Szpital dla Nerwowo i Psychicznie Chorych

    Świecie, 86-100
    Poland

    Active - Recruiting

  • Wojewódzki Szpital dla Psychicznie i Nerwowo Chorych

    Świecie, 86-100
    Poland

    Site Not Available

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

    Ivano-Frankivsk, 76014
    Ukraine

    Site Not Available

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

    Ivano-Frankivsk 707471, 76014
    Ukraine

    Site Not Available

  • 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

    Site Not Available

  • 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

    Site Not Available

  • 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 703448, 08631
    Ukraine

    Site Not Available

  • 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 703448, 04080
    Ukraine

    Site Not Available

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

    Lviv, 79021
    Ukraine

    Site Not Available

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

    Lviv, 79017
    Ukraine

    Site Not Available

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

    Lviv 702550, 79021
    Ukraine

    Site Not Available

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

    Lviv 702550, 79017
    Ukraine

    Site Not Available

  • 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

    Site Not Available

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

    Ternopil 691650, 46001
    Ukraine

    Site Not Available

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

    Vinnytsia, 21018
    Ukraine

    Site Not Available

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

    Vinnytsia 689558, 21018
    Ukraine

    Site Not Available

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