A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT01493726
First received: December 12, 2011
Last updated: August 9, 2013
Last verified: August 2013
  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, Inc.:

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 ]

Enrollment: 88
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: June 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493726

Locations
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
St. 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
Study Director: Robert Risinger, MD Alkermes, Inc.
  More Information

No publications provided

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01493726     History of Changes
Other Study ID Numbers: ALK9072-002
Study First Received: December 12, 2011
Last Updated: August 9, 2013
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 September 16, 2014