Phase 3
Completed N=291
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Source: ClinicalTrials.gov NCT01895452 ↗Enrolled (actual)
291
Serious AEs
1.4%
Results posted
Aug 2017
Primary outcomePrimary: Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs) — 21; 94 Participants
◆ Published Evidence
Emerging
7citations · ~1 / year
Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia.
Summary
This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.
Linked Publications (2)
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Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia.
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Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs) |
21; 94 | — |
| SECONDARY Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time |
-0.7; -0.9 | — |
| SECONDARY Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time |
-0.1; -0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Completed the treatment period of Study ALK9072-003EXT
- Continues to require chronic treatment with an antipsychotic medication
- Continues to reside in a stable living situation
- Continues to have an identified reliable informant
Exclusion Criteria
- Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug
- Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT
- Has a significant or unstable medical condition that would preclude safe completion of the current study
- Subject is pregnant or breastfeeding
- Subject expects to be incarcerated, or has pending legal action which may impact compliance with study participation or procedures
Data sourced from ClinicalTrials.gov (NCT01895452) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.