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

December 12, 2011
August 9, 2013
December 2011
June 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01493726 on ClinicalTrials.gov Archive Site
Number of Participants with Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: ALKS 9072, Low dose
    IM injection, given monthly
  • Drug: ALKS 9072, Med dose
    IM injection, given monthly
  • Drug: ALKS 9072, High dose
    IM injection, given monthly
  • Drug: Placebo
    Dosed matched placebo IM injection, given monthly
  • Experimental: ALKS 9072, Low dose
    Intervention: Drug: ALKS 9072, Low dose
  • Experimental: ALKS 9072, Med dose
    Intervention: Drug: ALKS 9072, Med dose
  • Experimental: ALKS 9072, High dose
    Intervention: Drug: ALKS 9072, High dose
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01493726
ALK9072-002
No
Alkermes, Inc.
Alkermes, Inc.
Not Provided
Study Director: Robert Risinger, MD Alkermes, Inc.
Alkermes, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP