Trial record 11 of 50 for:
Alkermes
A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
This study is currently recruiting participants.
Verified February 2012 by Alkermes
Sponsor:
Alkermes
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT01493726
First received: December 12, 2011
Last updated: February 8, 2012
Last verified: February 2012
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Purpose
This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072 (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: ALKS 9072, Low dose Drug: ALKS 9072, Med dose Drug: ALKS 9072, High dose Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ALKS 9072 in Subjects With Chronic Stable Schizophrenia |
Resource links provided by NLM:
Further study details as provided by Alkermes:
Primary Outcome Measures:
- Maximum concentration in plasma following last dose [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Time to maximum concentration in plasma following last dose [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Area under the plasma concentration time curve over the last dosing interval [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants with Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ALKS 9072, Low dose |
Drug: ALKS 9072, Low dose
IM injection, given monthly
|
| Experimental: ALKS 9072, Med dose |
Drug: ALKS 9072, Med dose
IM injection, given monthly
|
| Experimental: ALKS 9072, High dose |
Drug: ALKS 9072, High dose
IM injection, given monthly
|
| Placebo Comparator: Placebo |
Drug: Placebo
Dosed matched placebo IM injection, given monthly
|
Detailed Description:
Three active treatment groups and a placebo group are planned. Randomization will be sequential by dose level across the sites with placebo assignments randomly inserted. Each subject's participation will be approximately 8 months, including screening, treatment period, and a 3-month follow-up period.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of chronic schizophrenia that is clinically stable
- Body mass index (BMI) between 18.5 and 35.0 kg/m2, inclusive
- Stable antipsychotic medication regimen for >/= 2 months before Screening
- Be willing and able to be confined to an inpatient clinical research unit for a total of 37 days during the course of the study
Exclusion Criteria:
- Aripiprazole used within 30 days before Screening
- History of intolerance of or allergy or hypersensitivity to aripiprazole, its excipients, other antipsychotic agents, or INTRALIPID (including peanuts, soy, egg, or glycerol)
- Current diagnosis of an Axis I disorder other than schizophrenia
- History of seizure disorder or any condition associated with seizures
- History of neuroleptic malignant syndrome (NMS)
- Positive test result for HIV, hepatitis B surface antigen, or anti-hepatitis C antibodies
- Received medication by IM injection within 30 days before Screening
- Monoamine oxidase inhibitors (eg, phenelzine, tranylcypromine, selegiline) used within 30 days before Screening
- DSM-IV-TR diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence within 12 months before Screening
- Donation of blood or blood components within 4 weeks before Screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493726
Contacts
| Contact: Chris Southard | 919-418-4823 | csouthard@INCResearch.com |
Locations
| United States, Georgia | |
| Alkermes Investigational Site | Recruiting |
| Atlanta, Georgia, United States, 30338 | |
| United States, Illinois | |
| Alkermes Investigational Site | Recruiting |
| Hoffman Estates, Illinois, United States, 60169 | |
| United States, Missouri | |
| Alkermes Investigational Site | Recruiting |
| St. Louis, Missouri, United States, 63118 | |
| United States, New Jersey | |
| Alkermes Investigational Site | Recruiting |
| Willingboro, New Jersey, United States, 08046 | |
| United States, Pennsylvania | |
| Alkermes Investigational Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19139 | |
| United States, Texas | |
| Alkermes Investigational Site | Recruiting |
| Irving, Texas, United States, 70562 | |
Sponsors and Collaborators
Alkermes
Investigators
| Study Director: | Robert Risinger, MD | Alkermes |
More Information
No publications provided
| Responsible Party: | Alkermes |
| ClinicalTrials.gov Identifier: | NCT01493726 History of Changes |
| Other Study ID Numbers: | ALK9072-002 |
| Study First Received: | December 12, 2011 |
| Last Updated: | February 8, 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 19, 2013