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A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01493726
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: ALKS 9072, Low dose Drug: ALKS 9072, Med dose Drug: ALKS 9072, High dose Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Maximum concentration in plasma following last dose [ Time Frame: 4 months ]
  2. Time to maximum concentration in plasma following last dose [ Time Frame: 4 months ]
  3. Area under the plasma concentration time curve over the last dosing interval [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: 4 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493726


Locations
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United States, Georgia
Alkermes Investigational Site
Atlanta, Georgia, United States, 30338
United States, Illinois
Alkermes Investigational Site
Hoffman Estates, Illinois, United States, 60169
United States, Missouri
Alkermes Investigational Site
Saint Louis, Missouri, United States, 63118
United States, New Jersey
Alkermes Investigational Site
Willingboro, New Jersey, United States, 08046
United States, Pennsylvania
Alkermes Investigational Site
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Alkermes Investigational Site
Irving, Texas, United States, 70562
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Alkermes Medical Director, MD Alkermes, Inc.
Publications of Results:
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01493726    
Other Study ID Numbers: ALK9072-002
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders