E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039626 |
E.1.2 | Term | Schizophrenia |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
•To evaluate the efficacy and safety of lumateperone relative to placebo in the prevention of relapse of symptoms in patients with schizophrenia. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Provide written informed consent (signed or thumb-printed, in accordance with local regulations to ensure protection of patient’s rights) obtained before the initiation of any study procedures; 2.Patient must identify a caregiver who provides consent to participate in the study; 3.Male or female, 18 to 60 years of age, inclusive; 4.Current diagnosis of schizophrenia according to DSM-5 criteria as determined by the modified Structured Clinical Interview for DSM- 5 (modified SCID-5-CT); 5.Diagnosis of schizophrenia for a minimum of 1 year before Visit 1; 6.Current psychotic episode < 4 weeks duration at Visit 1; 7.Positive and Negative Syndrome Scale (PANSS) total score ≥ 70 and≤ 120 at Visit 1 and Visit 2. 8.Rating of ≥ 4 (moderate) on at least 2 of the following PANSS positive symptoms at Screening (Visit 1) and Baseline (Visit 2): delusions (P1); hallucinatory behavior (P3); conceptual disorganization (P2); and suspiciousness/persecution (P6). All Inclusion Criteria are presented in Protocol Section 6.4.1.
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E.4 | Principal exclusion criteria |
1.Currently meets DSM-5 criteria for any of the following: a.Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders, except for schizophrenia; b.Bipolar I or Bipolar II disorder; c.Intellectual developmental disorder, delirium, dementia, amnestic and other cognitive disorders; d.Known or suspected borderline or antisocial personality disorder or other DSM-5 personality disorder of sufficient severity to interfere with participation in this study; e.Substance use disorder (other than nicotine) within the 3 months prior to Visit 1 of this study; 2.Patients in their first episode of psychosis; 3.Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 courses of antipsychotic treatment of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the package insert for the antipsychotic treatment); 4.History of intolerance or hypersensitivity to a typical or atypical antipsychotic or to designated rescue medications or any history of severe drug allergy or hypersensitivity; All Exclusion Criteria are presented in Protocol Section 6.4.2.
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E.5 End points |
E.5.1 | Primary end point(s) |
Relapse during the DBTP is defined as meeting 1 or more of the following relapse criteria: •Psychiatric hospitalization or need for increased level of psychiatric care due to worsening of the patient’s underlying condition; •Demonstrate an increase in PANSS total score by ≥ 30% for patients with PANSS total score ≥ 50 at randomization or demonstrate a ≥ 10- point or more increase in PANSS total score for patients who scored < 50 at randomization. NOTE: Patients should also meet this criterion at a second assessment that is 4 to 7 days apart unless, based on Investigator discretion, a second assessment cannot be performed due to severity of symptoms; •Demonstrate an increase ≥ 2 points in the Visit 14 Clinical Global Impression Scale-Severity (CGI-S) score. NOTE: The patient should also meet this criterion at a second assessment that is 4 to 7 days apart unless, based on Investigator discretion, a second assessment cannot be performed due to severity of symptoms; •Deliberate self-injury or aggressive/violent behavior; •Suicidal or homicidal ideation; •PANSS item scores > 4 on 1 or more of the following PANSS items: P1, P2, P3, P6, P7, G8 or G14. NOTE: The patient should also meet this criterion at a second assessment that is 4 to 7 days apart unless, based on Investigator discretion, a second assessment cannot be performed due to severity of symptoms.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary efficacy endpoint is time to first symptom relapse during the DBTP, defined as the number of days from the randomization date to the first relapse date. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Open-label (PR2), Double-blind Treatment (PR1) |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Ukraine |
Serbia |
United States |
Bulgaria |
Croatia |
Poland |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |