E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Maintenance treatment of schizophrenia in patients currently treated with oral antipsychotics |
Traitement d'entretien de la schizophrénie chez les patients actuellement traités par antipsychotiques oraux |
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E.1.1.1 | Medical condition in easily understood language |
Maintenance treatment of schizophrenia in patients currently treated with oral antipsychotics |
Traitement d'entretien de la schizophrénie chez les patients actuellement traités par antipsychotiques oraux |
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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 |
The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000 administered in adult and adolescent patients with schizophrenia. |
L’objectif principal de cette étude est d’évaluer la sécurité et la tolérance à long terme du TV-46000 administré à des patients adultes et adolescents atteints de schizophrénie. |
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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 |
Roll over patients: The patient must have participated in the pivotal efficacy study (Study TV46000-CNS-30072) without experiencing relapse events and without important protocol deviations.
New Patients: The patient has a diagnosis of schizophrenia according to the DSM-5 for >1 year (diagnosis must be reconfirmed by SCID-5) and ≥1 episode of relapse in the last 24 months.
please refer to the protocol for additional inclusion criteria |
Patients issus de l’étude pivot d’efficacité Le/la patient(e) doit avoir participé à l’étude pivot d’efficacité (étude TV46000-CNS-30072) sans avoir présenté d’événement de rechute et sans déviation majeure du protocole.
Nouveaux patients Le diagnostic de schizophrénie a été posé selon le DSM-5 et date de plus d’un an (le diagnostic doit être reconfirmé au moyen d’un SCID-5), et le/la patient(e) a présenté au moins un épisode de rechute au cours des 24 derniers mois.
Veuillez vous référer au protocole pour les critères d'inclusion supplémentaires. |
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E.4 | Principal exclusion criteria |
Roll Over and New patients: The patient has a current clinically significant DSM-5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, or amnestic or other cognitive disorders, or borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
please refer to the protocol for additional exclusion criteria. |
Patients issus de l’étude pivot d’efficacité et nouveaux patients: Le patient présente actuellement une pathologie cliniquement significative diagnostiquée selon le DSM-5 (autre que la schizophrénie) notamment : trouble schizoaffectif, trouble dépressif majeur, trouble bipolaire, délire, démence, trouble amnésique ou autre trouble cognitif, ou trouble de la personnalité limite, paranoïaque, histrionique, schizotypique, schizoïde ou antisocial.
Veuillez vous référer au protocole pour les critères d'inclusion supplémentaires. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the frequency of all adverse events, including serious adverse events. |
Le critère d'évaluation principal est la fréquence de tous les événements indésirables, y compris les événements indésirables graves. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
All scheduled and any unscheduled visit of the study period |
Toutes les visites programmées et toutes les visites non programmées de la période d'étude. |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
E.8.1.5 | Parallel group | Yes |
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 | 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.8.6 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 |
Bulgaria |
Canada |
France |
Israel |
United States |
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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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End of study (EoS) is defined as the date when the last patient in Stage 2 has completed all efficacy and safety assessments at the final visit per protocol (Follow-up Visit 2). |
La fin de l’étude est définie comme la date à laquelle le dernier patient de l’étape 2 a terminé toutes les évaluations d’efficacité et de sécurité lors de la visite finale par protocole (visite de suivi 2). |
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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 | |
E.8.9.1 | In the Member State concerned months | 22 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 22 |