| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Adolescent patient (13-17 years of age) with Schizophrenia |
|
| E.1.1.1 | Medical condition in easily understood language |
| Adolescent patient (13-17 years of age) with Schizophrenia |
|
| 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 |
|
| 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 long-term safety and tolerability of cariprazine (1.5 mg/d to 6.0 mg/d) in the treatment of adolescents (13 to <18 years of age) with schizophrenia. |
|
| E.2.2 | Secondary objectives of the trial |
To assess health-related outcomes during long-term treatment with cariprazine (1.5 mg/d to 6.0 mg/d) in adolescent patients (13-<18 years of age) with schizophrenia.
To evaluate the long-term effectiveness of cariprazine (1.5 mg/d to 6.0 mg/d) in the treatment of adolescents (13 to <18 years of age) with schizophrenia. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
- In addition to the informed consent given by the parent(s) or legal representative assent of the patient must be obtained for participating in the study prior to any study related procedures
- Male or female patients must be 13 to <18 years of age at the time of obtaining the patient’s informed consent or assent. Patients who turn 18 during RGH-MD-20 are permitted to continue in this trial. De novo patients are required to be <18 years of age at screening.
- Patients with a DSM-5 primary diagnosis of schizophrenia, which has been confirmed by the K-SADS-PL administered by a trained clinician.
- PANSS total score ≤ 60 at Screening and Baseline.
- Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8 and G14 at Screening and Baseline.
-CGI-S score ≤ 4 at Screening and Baseline.
- Patients must agree to sexual abstinence or to use a highly effective contraceptive method (see Section 16.1) during the study and for 10 weeks after the last dose of the IMP. Male patients must agree to refrain from donating sperm during this period. Women using systematically acting hormonal contraceptives should add a second barrier method (e.g. male condom, diaphragm or cervical cap).
- Patient must have a caregiver who is willing and able to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of study intervention, and accompany the patient to all study visits. Written consent from the caregiver must be obtained. |
|
| E.4 | Principal exclusion criteria |
- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
- Patient has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobaccorelated) within the 3 months before Screening
- Patient with acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hyper- or hypothyroidism, acute systemic infection, renal, gastrointestinal, respiratory, or cardiovascular disease.
- Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 antipsychotic trials of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the drug’s package insert).
- Patient requires concomitant treatment with moderate or strong cytochrome P450 (CYP) 3A4 inhibitors or inducers. If applicable and the patient's condition allows without risk, these drugs must be discontinued 7 days or at least 5 half-lives of the drug (whichever is longer) prior to Baseline (Visit 2).
- Patient requires concomitant treatment with any prohibited medication, supplement or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component with the exception of permitted treatment
- Positive UDS for substances of abuse at Screening. Exception: patients with a positive UDS at Screening for opiates, cannabinoids, amphetamines, or benzodiazepines may be allowed in the study provided all 3 of the following apply:
o The drug was used for a legitimate medical purpose with the exception of poppy seed consumption;
o The drug can be discontinued prior to further participation in the study (except for benzodiazepines which may be continued if the dose [lorazepam up to 2 mg/d or its benzodiazepine equivalent, with the exception of phenazepam] has been stable for at least 1 month prior to Baseline (Visit 2) or if used as a rescue medication, consistent with section 10.7.2. and 10.7.3 in the protocol.)
o A repeat UDS is negative for these substances prior to Baseline (Visit 2), except benzodiazepine use as described above.
- Patients who meet any of the following ophthalmological criteria:
o A history of cataracts
o Any clinically significant ocular trauma or complications of ocular trauma, or history of retinal detachment, intraocular surgery or laser treatment
o History of ocular disease (open- or narrow-angle glaucoma, retinopathies, corneal diseases)
o History of amiodarone or systemic corticosteroid use for ≥ 3 consecutive months in the past year
- For female patients, positive pregnancy test at Screening or nursing or planning a pregnancy at any time during participation in the study.
- History of suicide attempt within 6 months of Screening in the judgement of the Investigator.
- Current suicidal or homicidal ideation judged clinically significant by the Investigator.
Please refer to section 9.2 of the protocol for more information. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary Outcome Measures:
adverse events, clinical laboratory assessments including HbA1c, prolactin, FSH and LH, menstrual cycle assessment, vital signs, weight, physical examination, ECG, C-SSRS, CDSS, AIMS, BARS, SAS, UKU and Tanner staging |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| From baseline to week 104 |
|
| E.5.2 | Secondary end point(s) |
Additional Outcome Measures:
Effectiveness measures: PANSS, CGI-S, CGI-I, C-GAS, CDR system
Health-related outcome measures: CGSQ, PQ-LES-Q |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| From baseline to week 104 |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| 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 | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| 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 | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| 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 | 2 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 25 |
| 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 |
| Argentina |
| Colombia |
| Ukraine |
| Mexico |
| Russian Federation |
| Serbia |
| Bulgaria |
| Czechia |
| Germany |
| Hungary |
| Poland |
| Romania |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 5 |
| E.8.9.1 | In the Member State concerned months | 11 |
| E.8.9.1 | In the Member State concerned days | 16 |
| E.8.9.2 | In all countries concerned by the trial years | 6 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
| E.8.9.2 | In all countries concerned by the trial days | 17 |
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