A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

Schizophrenia Clinical Trial

Official title:

A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626456
• Other study ID #: ALK9072-003EXT
• Status: Completed
• Phase: Phase 3
• Start date: June 2012
• Est. completion date: April 2015

Study information

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

Clinical Trial Summary

This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

(Subjects who participated in ALK9072-003)

• Completed the ALK9072-003 Day 85 visit

• Continues to require treatment with an antipsychotic medication

(New Subjects)

• On a stable dose of oral antipsychotic medication

• Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable

• Has been able to achieve outpatient status for more than 3 months prior to screening

• Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)

• Resides in a stable living situation

Exclusion Criteria:

(Subjects who participated in ALK9072-003)

• Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug

• Missed more than 1 scheduled study visit during participation in study ALK9072-003

• Has a significant or unstable medical condition that would preclude safe completion of the current study

• Subject is pregnant or breastfeeding

• Subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures

(New Subjects)

• History of poor or inadequate clinical response to treatment with aripiprazole

• History of treatment resistance

• Diagnosis of current substance dependence (including alcohol)

• Pregnant, lactating, or breastfeeding

• Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening

• Currently under involuntary hospitalization

• Current or expected incarceration

Additional inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• ALKS 9072, Low
IM injection, given monthly
• ALKS 9072, High
IM injection, given monthly

Locations

Country	Name	City	State
Bulgaria	Alkermes Investigational Site	Burgas
Bulgaria	Alkermes Investigational Site	Kazanlak
Bulgaria	Alkermes Investigational Site	Novi Iskar
Bulgaria	Alkermes Investigational Site	Pazardzhik
Bulgaria	Alkermes Investigational Site	Pleven
Bulgaria	Alkermes Investigational Site	Plovdiv
Bulgaria	Alkermes Investigational Site	Radnevo
Bulgaria	Alkermes Investigational Site	Ruse
Bulgaria	Alkermes Investigational Site	Sofia
Bulgaria	Alkermes Investigational Site	Stara Zagora
Bulgaria	Alkermes Investigational Site	Targovishte
Bulgaria	Alkermes Investigational Site	Veliko Tarnovo
Bulgaria	Alkermes Investigational Site	Vratsa
Korea, Republic of	Alkermes Investigational Site	Jeju-si
Korea, Republic of	Alkermes Investigational Site	Jeollanam-do
Korea, Republic of	Alkermes Investigational Site	Seoul
Malaysia	Alkermes Investigational Site	Cheras
Malaysia	Alkermes Investigational Site	Johor Bahru
Malaysia	Alkermes Investigational Site	Kuala Lumpur
Malaysia	Alkermes Investigational Site	Kuching
Philippines	Alkermes Investigational Site	Cebu City
Philippines	Alkermes Investigational Site	Iloilo City
Philippines	Alkermes Investigational Site	Mandaluyong City
Philippines	Alkermes Investigational Site	Manila
Philippines	Alkermes Investigational Site	Mariveles	Bataan
Philippines	Alkermes Investigational Site	Pasig City
Romania	Alkermes Investigational Site	Bucharest
Romania	Alkermes Investigational Site	Craiova
Romania	Alkermes Investigational Site	Iasi
Romania	Alkermes Investigational Site	Oradea
Romania	Alkermes Investigational Site	Targu Mures	Mures
Russian Federation	Alkermes Investigational Site	Khotkovo
Russian Federation	Alkermes Investigational Site	Lipetsk
Russian Federation	Alkermes Investigational Site	Moscow
Russian Federation	Alkermes Investigational Site	Nikol'skoye	Gatchinckiy
Russian Federation	Alkermes Investigational Site	Nizhniy Novgorod
Russian Federation	Alkermes Investigational Site	Rostov-on-Don
Russian Federation	Alkermes Investigational Site	Samara
Russian Federation	Alkermes Investigational Site	Saratov
Russian Federation	Alkermes Investigational Site	St. Petersburg
Russian Federation	Alkermes Investigational Site	Staritsa	Orenburg
Russian Federation	Alkermes Investigational Site	Stavropol
Russian Federation	Alkermes Investigational Site	Talagi
Russian Federation	Alkermes Investigational Site	Voronezh
Russian Federation	Alkermes Investigational Site	Yaroslavl
Ukraine	Alkermes Investigational Site	Chernigiv
Ukraine	Alkermes Investigational Site	Donetsk
Ukraine	Alkermes Investigational Site	Kharkiv
Ukraine	Alkermes Investigational Site	Kyiv
Ukraine	Alkermes Investigational Site	Lugansk
Ukraine	Alkermes Investigational Site	Lviv
Ukraine	Alkermes Investigational Site	Poltava
Ukraine	Alkermes Investigational Site	Simferopol
Ukraine	Alkermes Investigational Site	Stepanovka	Kherson
Ukraine	Alkermes Investigational Site	Ternopil
Ukraine	Alkermes Investigational Site	Uzhgorod
Ukraine	Alkermes Investigational Site	Vinnytsia
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Austin	Texas
United States	Alkermes Investigational Site	Austin	Texas
United States	Alkermes Investigational Site	Charleston	South Carolina
United States	Alkermes Investigational Site	Chicago	Illinois
United States	Alkermes Investigational Site	Chicago	Illinois
United States	Alkermes Investigational Site	Creve Coeur	Missouri
United States	Alkermes Investigational Site	Dallas	Texas
United States	Alkermes Investigational Site	Dallas	Texas
United States	Alkermes Investigational Site	Fort Lauderdale	Florida
United States	Alkermes Investigational Site	Garden Grove	California
United States	Alkermes Investigational Site	Hoffman Estates	Illinois
United States	Alkermes Investigational Site	La Habra	California
United States	Alkermes Investigational Site	Leesburg	Florida
United States	Alkermes Investigational Site	Little Rock	Arkansas
United States	Alkermes Investigational Site	Little Rock	Arkansas
United States	Alkermes Investigational Site	Oakland	California
United States	Alkermes Investigational Site	Oceanside	California
United States	Alkermes Investigational Site	Overland Park	Kansas
United States	Alkermes Investigational Site	Philadelphia	Pennsylvania
United States	Alkermes Investigational Site	Rockville	Maryland
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	San Diego	California
United States	Alkermes Investigational Site	Springdale	Arkansas
United States	Alkermes Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Korea, Republic of,  Malaysia,  Philippines,  Romania,  Russian Federation,  Ukraine, 

References & Publications (1)

Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.000000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Treatment-emergent Adverse Events (TEAEs)	This measure includes incidences >5%.	52 weeks
Secondary	Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)	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 Day 365 based on the observed data.	52 weeks
Secondary	Discontinuation From Study Due to Adverse Events (AEs)	Number of subjects who discontinued the study due to AE.	52 weeks
Secondary	Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)	The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.	52 weeks
Secondary	Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests	Includes incidence >2% but <5%.	52 weeks
Secondary	Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores	This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).	52 weeks