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NCT01895452 Clinical Trial

An Extension of 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 ALK9072-003EXT 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 NCT01895452
Other study ID # ALK9072-003EXT2
Secondary ID
Status Completed
Phase Phase 3
First received July 5, 2013
Last updated July 13, 2016
Start date July 2013
Est. completion date June 2016

Study information
Verified date July 2016
Source Alkermes, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencyKorea: Ministry of Food and Drug SafetyMalaysia: Ministry of HealthPhilippines: Department of HealthRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationUkraine: Ministry of Health
Study type Interventional

Clinical Trial Summary

This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.

Recruitment information / eligibility
Status Completed
Enrollment 291
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Completed the treatment period of Study ALK9072-003EXT

- Continues to require chronic treatment with an antipsychotic medication

- Continues to reside in a stable living situation

- Continues to have an identified reliable informant

Exclusion Criteria:

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

- Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT

- 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, or has pending legal action which may impact compliance with study participation or procedures

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ALKS 9072, Low Dose
Intramuscular injection, given monthly
• ALKS 9072, High Dose
Intramuscular injection, given monthly

Locations
Country Name City State
Bulgaria Alkermes Investigational Site Burgas
Bulgaria Alkermes Investigational Site Novi Iskar
Bulgaria Alkermes Investigational Site Pazardzhik
Bulgaria Alkermes Investigational Site Plovdiv
Bulgaria Alkermes Investigational Site Sofia
Bulgaria Alkermes Investigational Site Targovishte
Bulgaria Alkermes Investigational Site Veliko Tarnovo
Bulgaria Alkermes Investigational Site Vratsa
Korea, Republic of Alkermes Investigational Site Jeollanam-do
Malaysia Alkermes Investigational Site Cheras
Malaysia Alkermes Investigational Site Johor Bahru
Malaysia Alkermes Investigational Site Kuala Lampur
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
Romania Alkermes Investigational Site Bucharest
Romania Alkermes Investigational Site Oradea
Romania Alkermes Investigational Site Targu Mures
Russian Federation Alkermes Investigational Site Lipetsk
Russian Federation Alkermes Investigational Site Moscow
Russian Federation Alkermes Investigational Site Roshchino Vyborgskiy
Russian Federation Alkermes Investigational Site Rostov-on-Don
Russian Federation Roshchino township Samara
Russian Federation Roshchino township Saratov
Russian Federation Alkermes Investigational Site St. Petersburg
Russian Federation Alkermes Investigational Site Stavropol
Russian Federation Alkermes Investigational Site Talagi
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 Kherson
Ukraine Alkermes Investigational Site Kyiv
Ukraine Alkermes Investigational Site Lviv
Ukraine Alkermes Investigational Site Poltava
Ukraine Alkermes Investigational Site Ternopil
Ukraine Roshchino township Vinnytsia
United States Alkermes Investigational Site Atlanta Georgia
United States Alkermes Investigational Site Chicago Illinois
United States Alkermes Investigational Site Chicago Illinois
United States Alkermes Investigational Site Dallas Texas
United States Alkermes Investigational Site Dallas Texas
United States Alkermes Investigational Site Ft. Lauderdale Florida
United States Alkermes Investigational Site Garden Grove California
United States Alkermes Investigational Site Hoffman Estates Illinois
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 Oklahoma City Oklahoma
United States Alkermes Investigational Site Orange California
United States Alkermes Investigational Site Shreveport Louisiana
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, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number and percentage of subjects with treatment-emergent adverse events (TEAEs) 12 months No
Secondary Change in baseline of Positive and Negative Syndrome Scale (PANSS) total score over time 12 months No
Secondary Mean change from baseline to endpoint in Clinical Global Impression - Severity (CGI-S) over time 12 months No
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