Safety and Tolerability of Cariprazine in the Treatment of Adolescent Patients with Schizophrenia

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gedeon Richter Plc.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

20 Feb 2020 → ongoing

Decision date (initial)

2024-07-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Gedeon Richter Plc

External identifiers

EU CT number

2024-513222-30-00

EudraCT number

2018-004590-27

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Efficacy, Safety

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.

Secondary objectives 1

1. 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. 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.

Conditions and MedDRA coding

Adolescent patient (13-17 years of age) with Schizophrenia

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-001652-PIP01-14

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 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
2. 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.
3. Patients with a DSM-5 primary diagnosis of schizophrenia, which has been confirmed by the K-SADS-PL administered by a trained clinician
4. PANSS total score ≤ 60 at Screening and Baseline
5. Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8 and G14 at Screening and Baseline
6. CGI-S score ≤ 4 at Screening and Baseline
7. 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)

Exclusion criteria 5

1. Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
2. Patient has a history of meeting DSM-5 diagnosis for any substancerelated disorder (except caffeine- and tobaccorelated) within the 3 months before Screening
3. 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.
4. 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)
5. 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).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 1

1. "Additional Outcome Measures: Effectiveness measures: PANSS, CGI-S, CGI-I, C-GAS, CDR system Health-related outcome measures: CGSQ, PQ-LES-Q Per p Additional Outcome Measures: Effectiveness measures: PANSS, CGI-S, CGI-I, C-GAS, CDR system Health-related outcome measures: CGSQ, PQ-LES-Q Per p"

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gedeon Richter Plc.

Sponsor organisation

Gedeon Richter Plc.

Address

Gyomroi Ut 19-21

City

Budapest X

Postcode

1103

Country

Hungary

Scientific contact point

Organisation

Gedeon Richter Plc.

Contact name

MedicalInformationScientificService

Public contact point

Organisation

Gedeon Richter Plc.

Contact name

MedicalInformationScientificService

Third parties 5

Locations

3 EU/EEA countries · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications