Phase 3
N=478
A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01626456 ↗Enrolled (actual)
478
Serious AEs
3.1%
Results posted
Oct 2016
Primary outcome: Primary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) — 51; 190 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ALKS 9072, Low (Drug); ALKS 9072, High (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alkermes, Inc.
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Treatment-emergent Adverse Events (TEAEs) |
51; 190 | — |
| SECONDARY Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S) |
-0.9; -0.5; -0.8; -0.3; -0.2 | — |
| SECONDARY Discontinuation From Study Due to Adverse Events (AEs) |
2; 27 | — |
| SECONDARY Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS) |
0; 1; 1; 1; 4; 0 | — |
| SECONDARY Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests |
1; 0; 2; 3; 12; 1 | — |
| SECONDARY Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores |
-19.1; -10.0; -11.6; -8.3; -5.9; -5.8 | — |
Summary
This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.
Eligibility Criteria
Inclusion Criteria
(Subjects who participated in ALK9072-003)
- Completed the ALK9072-003 Day 85 visit
- Continues to require treatment with an antipsychotic medication
(New Subjects)
- On a stable dose of oral antipsychotic medication
- Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable
- Has been able to achieve outpatient status for more than 3 months prior to screening
- Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
- Resides in a stable living situation
Exclusion Criteria
(Subjects who participated in ALK9072-003)
- Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug
- Missed more than 1 scheduled study visit during participation in study ALK9072-003
- 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 in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures
(New Subjects)
- History of poor or inadequate clinical response to treatment with aripiprazole
- History of treatment resistance
- Diagnosis of current substance dependence (including alcohol)
- Pregnant, lactating, or breastfeeding
- Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening
- Currently under involuntary hospitalization
- Current or expected incarceration
Additional inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01626456). 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.