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A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

Sponsor
Alkermes, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01493726
Collaborator
(none)
88
Enrollment
6
Locations
4
Arms
18
Duration (Months)
14.7
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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 :
Dec 1, 2011
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Maximum concentration in plasma following last dose [4 months]

  2. Time to maximum concentration in plasma following last dose [4 months]

  3. Area under the plasma concentration time curve over the last dosing interval [4 months]

Secondary Outcome Measures

  1. Number of Participants with Adverse Events [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Alkermes Investigational Site Atlanta Georgia United States 30338
2 Alkermes Investigational Site Hoffman Estates Illinois United States 60169
3 Alkermes Investigational Site Saint Louis Missouri United States 63118
4 Alkermes Investigational Site Willingboro New Jersey United States 08046
5 Alkermes Investigational Site Philadelphia Pennsylvania United States 19139
6 Alkermes Investigational Site Irving Texas United States 70562

Sponsors and Collaborators

  • Alkermes, Inc.

Investigators

  • Study Director: Alkermes Medical Director, MD, Alkermes, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT01493726
Other Study ID Numbers:
  • ALK9072-002
First Posted:
Dec 16, 2011
Last Update Posted:
Aug 29, 2018
Last Verified:
Aug 1, 2018
Additional relevant MeSH terms:
Schizophrenia

Study Results

No Results Posted as of Aug 29, 2018