NCT02634320

Brief Summary

This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as ARISTADA, ALKS 9070).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 8, 2018

Completed
Last Updated

December 4, 2018

Status Verified

November 1, 2018

Enrollment Period

1.6 years

First QC Date

December 16, 2015

Results QC Date

July 11, 2018

Last Update Submit

November 9, 2018

Conditions

Schizophrenia

Keywords

AlkermesARISTADAAripiprazole LauroxilSchizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores

    The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to last visit in the treatment period based on the observed data.

    Up to 7 months

Secondary Outcomes (5)

  • Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores

    Up to 7 months

  • Number of Participants With Adverse Events

    Up to 7 months

  • Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)

    Up to 7 months

  • Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)

    Up to 7 months

  • Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)

    Up to 7 months

Study Arms (1)

Aripiprazole Lauroxil

OTHER

Intramuscular (IM) injection

Drug: Aripiprazole Lauroxil

Interventions

Aripiprazole LauroxilDRUG

Monthly IM injection

Also known as: ARISTADA
Aripiprazole Lauroxil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has demonstrated tolerability to test doses of oral aripiprazole during screening; OR has a history of tolerated use of aripiprazole
  • Has a diagnosis of schizophrenia
  • Is clinically stable
  • Has received at least 3 doses of risperidone long acting injection (Risperdal Consta) or paliperidone palmitate (Invega Sustenna) prior to screening.
  • Has no antipsychotic medication regimen change for 4 weeks prior to Day 1
  • Agreed to abide by the contraceptive requirements o the protocol
  • Resides in a stable living situation
  • Additional criteria may apply

You may not qualify if:

  • Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
  • Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6 months of screening
  • Has participated in a clinical trial involving any investigational product within the past 3 months, or is currently participating in a clinical trial involving an investigational product
  • Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine, methadone, opiates, phencyclidine at screening
  • Additional criteria may apply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Alkermes Investigational Site

Little Rock, Arkansas, 27711, United States

Location

Alkermes Investigational Site

Rogers, Arkansas, 72758, United States

Location

Alkermes Investigational Site

Anaheim, California, 92805, United States

Location

Alkermes Investigational Site

Culver City, California, 90230, United States

Location

Alkermes Investigational Site

Garden Grove, California, 92845, United States

Location

Alkermes Investigational Site

National City, California, 91950, United States

Location

Alkermes Investigational Site

Oceanside, California, 92056, United States

Location

Alkermes Investigational Site

Orange, California, 92868, United States

Location

Alkermes Investigational Site

Panorama City, California, 91402, United States

Location

Alkermes Investigational Site

Augusta, Georgia, 30901, United States

Location

Alkermes Investigational Site

Chicago, Illinois, 60640, United States

Location

Alkermes Investigational Site

Shreveport, Louisiana, 71101, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63141, United States

Location

Alkermes Investigational Site

Garfield Heights, Ohio, 44125, United States

Location

Alkermes Investigational Site

Lincoln, Rhode Island, 02865, United States

Location

Alkermes Investigational Site

Dallas, Texas, 75231, United States

Location

Alkermes Investigational Site

Dallas, Texas, 75243, United States

Location

Alkermes Investigational Site

DeSoto, Texas, 75115, United States

Location

Related Publications (1)

  • Opler MGA, Claxton A, McGrory J, Gasper S, Wang M, Yagoda S. Functioning and Cognition in Patients with Schizophrenia After Initiating Treatment with Aripiprazole Lauroxil: Secondary Outcomes and Post Hoc Analysis. Innov Clin Neurosci. 2024 Mar 1;21(1-3):43-51. eCollection 2024 Jan-Mar.

    PMID: 38495608DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

aripiprazole lauroxil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
ARISTADA Medical Information
Organization
Alkermes, Inc.
usmedinfo@alkermes.com
866-204-7823

Study Officials

  • Sanjeev Pathak, MD

    Alkermes, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 18, 2015

Study Start

December 1, 2015

Primary Completion

July 11, 2017

Study Completion

July 11, 2017

Last Updated

December 4, 2018

Results First Posted

November 8, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(18)