CompletedPhase 2

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

Hungary, Poland, Ukraine189 participantsStarted 2021-05-19

Plain-language 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..

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in PANSS positive subscale at Day 28.

Timeframe: Day -1, Day 28

Trial details

NCT IDNCT05278156

SponsorCelon Pharma SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-05

View on ClinicalTrials.gov More Schizophrenia trials