Trial record 10 of 50 for:
Alkermes
A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
This study is currently recruiting participants.
Verified August 2012 by Alkermes
Sponsor:
Alkermes
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT01626456
First received: June 15, 2012
Last updated: August 14, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: ALKS 9072, Low Drug: ALKS 9072, High |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia |
Resource links provided by NLM:
Further study details as provided by Alkermes:
Primary Outcome Measures:
- Number of subjects with treatment-emergent adverse events (TEAEs) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Percentage of subjects with TEAEs [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean change from baseline to endpoint in Clinical Global Impression Scale for Severity (CGI-S) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Discontinuation from study due to Adverse Events (AEs) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Suicidality will be summarized by change from baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Incidence of clinically significant changes will be calculated for movement disorders, vital signs and routine laboratory tests [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Positive and Negative Syndrome Scale (PANSS) total score and subscale scores [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]Total defined as sum of positive, negative, and general psychopathology subscale scores; subscale defined as positive, negative, general psychopathology scores
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ALKS 9072, Low |
Drug: ALKS 9072, Low
IM injection, given monthly
|
| Experimental: ALKS 9072, High |
Drug: ALKS 9072, High
IM injection, given monthly
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626456
Contacts
| Contact: Chris Southard | 919-418-4823 |
Locations
| United States, Arkansas | |
| Alkermes Investigational Site | Recruiting |
| Little Rock, Arkansas, United States, 72211 | |
| United States, California | |
| Alkermes Investigational Site | Recruiting |
| Garden Grove, California, United States, 92845 | |
| Alkermes Investigational Site | Recruiting |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| Alkermes Investigational Site | Recruiting |
| Ft. Lauderdale, Florida, United States, 33308 | |
| United States, Georgia | |
| Alkermes Investigational Site | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Alkermes Investigational Site | Recruiting |
| Chicago, Illinois, United States, 60640 | |
| United States, Kansas | |
| Alkermes Investigational Site | Recruiting |
| Overland Park, Kansas, United States, 66212 | |
| United States, Maryland | |
| Alkermes Investigational Site | Recruiting |
| Rockville, Maryland, United States, 20850 | |
| United States, Texas | |
| Alkermes Investigational Site | Recruiting |
| Austin, Texas, United States, 78731 | |
| Alkermes Investigational Site | Recruiting |
| Dallas, Texas, United States, 75219 | |
Sponsors and Collaborators
Alkermes
Investigators
| Study Director: | Robert Risinger, MD | Alkermes |
More Information
No publications provided
| Responsible Party: | Alkermes |
| ClinicalTrials.gov Identifier: | NCT01626456 History of Changes |
| Other Study ID Numbers: | ALK9072-003EXT |
| Study First Received: | June 15, 2012 |
| Last Updated: | August 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013