Efficacy, Safety and Pharmacokinetics Study of CPL500036 (PDE10A Inhibitor) in Patients With Schi… (NCT05278156) | Clinical Trial Compass
CompletedPhase 2
Efficacy, Safety and Pharmacokinetics Study of CPL500036 (PDE10A Inhibitor) in Patients With Schizophrenia
Hungary189 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 range18 Years – 65 Years
SexALL
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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.
✕. The patient has uncontrolled abnormality which may impact the ability of the patient to participate or potentially confound the study results.
✕
What they're measuring
1
Change from baseline in PANSS positive subscale at Day 28.
. 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.