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 |
|
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 | 15.1 |
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 this open-label trial is to
evaluate the safety and tolerability of aripiprazole
intramuscular (IM) depot administered for 26 weeks to
subjects with schizophrenia. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female subjects 18 to 66 years of age, inclusive, at the time of informed consent.
2. Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the
initiation of any protocol-required procedures.
3. Ability, in the opinion of the investigator, to understand the nature of the trial and follow
protocol requirements, including the prescribed dosage regimens, tablet ingestion, and
discontinuation of prohibited concomitant medication, and to be reliably rated on assessment
scales.
4. Subjects who have met the completion criteria in the 31-12-291 registrational trial for the acute
treatment of adults with schizophrenia.
5. Subjects who, in the investigator’s judgment, require chronic treatment with antipsychotic
medication and would benefit from extended treatment with an IM depot formulation.
6. Outpatient status at the Week 12 visit in Trial 291. |
|
E.4 | Principal exclusion criteria |
1. Sexually active males of childbearing potential who do not agree to practice 2 different methods
of birth control or remain abstinent during the trial and for 180 days after the last dose of trial
medication. Sexually active WOCBP who do not agree to practice 2 different methods of birth
control or remain abstinent during the trial and for 150 days after the last dose of trial
medication.
2. Females who are breast-feeding and/or who have a positive pregnancy test result prior to
receiving IMP in this trial.
3. Subjects experiencing acute depressive symptoms within the past 30 days, according to the
investigator’s opinion, that requires treatment with an antidepressant.
4. Subjects who are anticipated needing CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers
during the course of the trial.
5. Subjects with a significant risk of violent behavior; who represent a risk of committing suicide;
or who in the clinical judgment of the investigator present a serious risk of suicide.
6. Subjects requiring any antipsychotic(s) other than aripiprazole IM depot after completion of
Trial 291.
7. Subjects likely to require prohibited concomitant therapy during the trial
8. Laboratory test and ECG results which are exclusionary
9.Any subject who, in the opinion of the investigator or medical monitor, should not participate in
the trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency and severity of AEs, serious AEs (clinical and
laboratory), and discontinuations from the trial due to AEs.
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The assessment of AEs will be monitored and recorded by the Physician at each visit every four weeks including a 26 week follow up phone call. |
|
E.5.2 | Secondary end point(s) |
Suicide risk as assessed and classified by the C-SSRS.
Extrapyramidal symptoms evaluated using the Simpson
Angus Scale (SAS), Abnormal Involuntary Movement
Scale (AIMS), and Barnes Akathisia Rating Scale (BARS).
Vital signs, laboratory tests, ECG parameters, body weight,
and physical examination findings. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Suicidality will be monitored throughout the trial using the C-SSRS at every visit.
Extrapyramidal Syptoms will be evaluated By SAS, AIMS and BARS at week 12 and week 24 visits.
Vital Signs will be monitored and recorded by the Physician at each visit every four weeks.
Lab test, ECG, Body weight will be measured at week 12 and week 24 visits. |
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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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
|
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 39 |
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 |
Colombia |
Croatia |
Egypt |
Indonesia |
Latvia |
Malaysia |
Mexico |
Philippines |
Poland |
Romania |
Russian Federation |
Serbia |
Slovakia |
Turkey |
Ukraine |
United States |
|
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
|
The End of Trial Date is defined as the last Date of Contact or the Date
of Final Contact Attempt from the Post-treatment Follow-up eCRF page
for the last subject completing or withdrawing from the trial. |
|
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 | 16 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial months | 16 |
E.8.9.2 | In all countries concerned by the trial days | 0 |