A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469039
• Other study ID #: ALK9072-003
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: March 2014

Study information

• Verified date: January 2019
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 623
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of schizophrenia according to DSM-IV-TR criteria

• Has been able to achieve outpatient status for more than 3 months in the past year

• Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)

• Resides in a stable living situation

• Willing and able to be confined to an inpatient study unit for 2 weeks or longer

Exclusion Criteria:

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

• History of treatment resistance

• Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)

• Diagnosis of current substance dependence (including alcohol)

• Pregnant, lactating, or breastfeeding

• Receipt of any antipsychotic medication by IM injection within 60 days before Screening

• Current involuntary hospitalization or incarceration

• Hospitalized for more than 30 days during the 90 days before Screening

Additional inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• ALKS 9072
Intramuscular (IM) injection, 441 mg or 882 mg given monthly
• Placebo
Placebo for 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	Bucharest
Romania	Alkermes Investigational Site	Craiova
Romania	Alkermes Investigational Site	Iasi
Romania	Alkermes Investigational Site	Oradea	Bihor
Romania	Alkermes Investigational Site	Targu Mures
Russian Federation	Alkermes Investigational Site	Khotkovo	Sergievo-Posadskiy
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	Primorsky
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	Vinnytsya
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	Cerritos	California
United States	Alkermes Investigational Site	Charleston	South Carolina
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	Orange	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 (9)

Cameron C, Zummo J, Desai D, Drake C, Hutton B, Kotb A, Weiden PJ. Efficacy and safety of aripiprazole lauroxil once-monthly versus aripiprazole once-monthly long-acting injectable formulations in patients with acute symptoms of schizophrenia: an indirect — View Citation

Cameron C, Zummo J, Desai DN, Drake C, Hutton B, Kotb A, Weiden PJ. Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison. Value Health. 2017 Jul - Aug;20(7):876-885. doi: 10.1016/j.jva — View Citation

Citrome L, Du Y, Risinger R, Stankovic S, Claxton A, Zummo J, Bose A, Silverman BL, Ehrich EW. Effect of aripiprazole lauroxil on agitation and hostility in patients with schizophrenia. Int Clin Psychopharmacol. 2016 Mar;31(2):69-75. doi: 10.1097/YIC.0000 — View Citation

Citrome L, Risinger R, Cutler AJ, Du Y, Zummo J, Nasrallah HA, Silverman BL. Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale-supportive analyses from a Phase 3 study. CNS Spectr. — View Citation

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

Meltzer HY, Risinger R, Nasrallah HA, Du Y, Zummo J, Corey L, Bose A, Stankovic S, Silverman BL, Ehrich EW. A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. J Clin Psychiatry. 2015 Aug;7 — View Citation

Nasrallah HA, Newcomer JW, Risinger R, Du Y, Zummo J, Bose A, Stankovic S, Silverman BL, Ehrich EW. Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related Safety Considerations Among Patients With Acute Schizophrenia. J Clin Psych — View Citation

Potkin SG, Risinger R, Du Y, Zummo J, Bose A, Silverman B, Stankovic S, Ehrich E. Efficacy and safety of aripiprazole lauroxil in schizophrenic patients presenting with severe psychotic symptoms during an acute exacerbation. Schizophr Res. 2017 Dec;190:11 — View Citation

Targum SD, Risinger R, Du Y, Pendergrass JC, Jamal HH, Silverman BL. Effect of patient age on treatment response in a study of the acute exacerbation of psychosis in schizophrenia. Schizophr Res. 2017 Jan;179:64-69. doi: 10.1016/j.schres.2016.09.034. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score	The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.	Data collected from baseline to day 85
Secondary	Clinical Global Impression - Improvement (CGI-I) Scores at Day 85	The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: "1: very much improved"; "2: much improved"; "3: minimally improved"; "4: no change"; "5: minimally worse"; "6: much worse"; or "7: very much worse".	85 Days

External Links

•   EU Clinical Trials Register; EudraCT number 2012-003445-15
•   Russian clinical trials website