A study to assess how safe ALKS 9072 is when given for a long time period and how long its effects continue when used for the treatment of schizophrenia

• Conditions: stable schizophrenia; MedDRA version: 17.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 17.1Level: LLTClassification code 10009134Term: Chronic schizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 17.1Level: LLTClassification code 10039632Term: Schizophrenia NOSSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-003996-20-BG
• Lead Sponsor: Alkermes, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-29
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Subjects Who Participated in ALK9072-003
1. Subject completed the ALK9072-003 Day 85 visit
2. Subject continues to require chronic treatment with an antipsychotic medication, in the opinion of the investigator
3. Subject continues to meet the contraceptive requirements of the study (see Section 7.5.1)
4. Subject is willing to continue, and has provided informed consent before initiation of any study specific procedures

New Subjects (Not Participated in ALK9072-003)
1. Subject is between 18 and 70 years old, inclusive, at screening
2. Subject is on a stable dose of oral antipsychotic medication and would potentially benefit from conversion to an extended release injectable, in the opinion of the investigator
3. Subject has a diagnosis of chronic schizophrenia (based on DSM-IV-TR criteria) that is clinically stable as evidenced by:
- No hospitalizations for acute exacerbations of schizophrenia within 3 months before
screening
- CGI-S score of = 3 (mild) at screening
4. Subject has previously had a clinically significant beneficial response (improvement in
schizophrenia symptoms), as determined by the investigator, to treatment with an antipsychotic medication other than clozapine
5. Subject has been able to achieve outpatient status for more than 3 consecutive months in the past year
6. Subject has a PANSS total score of less than 70 at screening
7. Subject has a BMI of 18.5 to 40.0 kg/m2 (inclusive) at screening
8. Subject resides in a stable living situation, in the opinion of the investigator
9. Subject has an identified reliable informant, in the opinion of the investigator
10. Subject meets contraceptive requirements defined in the protocol (see Section 7.5.1)
11. Subject is fluent (oral and written) in the language in which standardized tests will be administered, and can be reliably rated
12. Subject is willing and able to provide informed consent and subject has signed the informed consent form before initiation of any study specific procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Subjects Who Participated in ALK9072-003
1. Subject had an abnormal clinical laboratory, vital sign, or ECG finding during participation in
study ALK9072-003 that was clinically relevant and related to study drug, in the opinion of the
investigator
2. Subject was withdrawn from study ALK9072-003 due to a severe AE or a SAE, or
because of development of a serious medical condition or serious tolerability issues
3. Subject missed more than 1 scheduled study visit during participation in study ALK9072-003
4. Subject has a significant or unstable medical condition that would preclude safe completion of the current study
5. Subject requires use of a prohibited concomitant medication
6. Subject is pregnant or breastfeeding

New Subjects (Not Participated in ALK9072-003)
1. Subject has a history of poor or inadequate clinical response to treatment with aripiprazole
2. Subject has a history of treatment resistance, defined as failure to respond to 2 adequate trials of different antipsychotic medications (a minimum of 4 weeks at the subject's maximum tolerated dose)
3. Subject has a history of neuroleptic malignant syndrome, clinically significant tardive dyskinesia, tardive dystonia, or other medical condition that would convey undue risk or interfere with study assessments
4. Subject has clinically significant extrapyramidal symptoms at screening or baseline
5. Subject is at significant risk of suicidal, homicidal or violent ideation or behavior, by history or as clinically assessed by the investigator
6. Subject answers Yes” on items 4 or 5 of the C-SSRS (ideation) with the most recent episode occurring within the past 2 months, or answers Yes” to any of the 5 items (behavior) with an episode occurring within the last year
7. Subject has a diagnosis (according to DSM-IV-TR criteria) of substance (including alcohol)
dependence currently or within 6 months before screening or abuse within 3 months before
screening (exception: nicotine and caffeine dependence are allowed)
8. Subject has comorbid schizoaffective disorder, bipolar disorder, major depressive disorder,
dementia, delirium, amnestic or any other cognitive disorder currently or within the past 2 years
9. Subject has a clinically significant or unstable medical illness/condition/disorder that would be
anticipated, in the investigator’s opinion, to potentially compromise subject safety or adversely
affect the evaluation of durability of effect
10. Subject has clinically significant cardiac arrhythmia, cardiomyopathy, or cardiac conduction
defect, history of myocardial infarction or unstable angina within the last 3 months before
screening, or clinically significant abnormality on screening or baseline ECG including but not
limited to the following: QTcF > 465 msec for
11. Subject has a laboratory abnormality that, in the opinion of the investigator, would compromise the well-being of the subject, or any of the following laboratory abnormalities at screening or baseline:
? AST or ALT value = 2 times the upper limit of the laboratory normal reference range
? HbA1c > 9%
? Absolute neutrophil count ? Platelet count ? Serum creatinine > 2.5 mg/dL
? Positive test result for HIV, Hbs-Ag, or antihepatitis C virus antibody
? Urine drug screen at screening or baseline indicates illicit substance use with a positive
result for any of the tested substances
? Exception: results positive for benzodiazepines, opiates, or barbitu

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified