A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Safety and Tolerability of Initiating Aripiprazole Lauroxil in Subjects With Schizophrenia Who Are Inadequately Treated With Paliperidone Palmitate or Risperidone Long Acting Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634320
• Other study ID #: ALK9072-A401
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: July 11, 2017

Study information

• Verified date: November 2018
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 11, 2017
• Est. primary completion date: July 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole Lauroxil
Monthly IM injection

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Anaheim	California
United States	Alkermes Investigational Site	Augusta	Georgia
United States	Alkermes Investigational Site	Chicago	Illinois
United States	Alkermes Investigational Site	Culver City	California
United States	Alkermes Investigational Site	Dallas	Texas
United States	Alkermes Investigational Site	Dallas	Texas
United States	Alkermes Investigational Site	DeSoto	Texas
United States	Alkermes Investigational Site	Garden Grove	California
United States	Alkermes Investigational Site	Garfield Heights	Ohio
United States	Alkermes Investigational Site	Lincoln	Rhode Island
United States	Alkermes Investigational Site	Little Rock	Arkansas
United States	Alkermes Investigational Site	National City	California
United States	Alkermes Investigational Site	Oceanside	California
United States	Alkermes Investigational Site	Orange	California
United States	Alkermes Investigational Site	Panorama City	California
United States	Alkermes Investigational Site	Rogers	Arkansas
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores	The BPRS is an instrument for evaluating change in psychopathology in patients with schizophrenia. It consists of 18 items in which clinicians rate patient symptoms on a 7-point scale (1=not present, 7=extremely severe). Scores range from 18 to 126, with higher scores indicative of more severe psychopathology).	Up to 7 months
Secondary	Number of Participants With Adverse Events		Up to 7 months
Secondary	Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)	The QLS is a clinician-rated scale that is used to assess health-related quality of life and functioning in patients with schizoprehnia during the preceding 4 weeks. The QLS consists of 21 items in 4 major domains (Intrapsychic Foundations, Interpersonal Relations, Instrumental Role, and Common Objects and Activities). Following a semi-structured interview, each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning).	Up to 7 months
Secondary	Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)	Responses to 4 mTSR-6 questions have been provided. Results include the number of participants who responded positively to the category during the entire post-baseline treatment period.	Up to 7 months
Secondary	Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)	The BAS is a 19-item scale completed by the caregiver that focuses on specific subjective and objective consequences of families caring for individuals with severe mental disorders. Respondents are required to indicate whether they have experienced each of the types of burden - 'Not at all', 'A little', 'Some' or "A lot' - in the previous four weeks. These are scored 1, 2, 3 and 4, respectively. The total score ranges between 19 and 76. A higher score indicates more perceived burden. Subjects required a reliable informant (caregiver) in order to participate in the study. These caregivers did not receive study treatment, and they are not represented elsewhere in the results data. The data provided indicates the change from baseline to the last treatment visit.	Up to 7 months