Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified July 2024 by Alkermes, Inc.
Sponsor
Alkermes, Inc.
Information Provided by (Responsible Party)
Alkermes, Inc.
Clinicaltrials.gov Identifier
NCT03201757
Other Study ID Numbers:
ALK3831-A308
First Submitted
June 14, 2017
First Posted
June 27, 2017
Results First Posted
August 25, 2024
Last Update Posted
September 25, 2024
Last Verified
July 2024

ClinicalTrials.gov processed this data on September 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
SchizophreniaSchizophreniform DisorderBipolar I Disorder
Drug: ALKS 3831

Study Design

Study TypeInterventional
Actual Enrollment523 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder
Study Start DateJune 14, 2017
Actual Primary Completion DateSeptember 5, 2023
Actual Study Completion DateSeptember 5, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
ALKS 3831
Coated bilayer tablet
Drug: ALKS 3831
Olanzapine + samidorphan, daily oral dosing

Outcome Measures

Primary Outcome Measures
  1. Incidence of Adverse Events
  2. Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
    The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Willing and able to give informed consent/assent as per local requirements
Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal
Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator
Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307
Additional criteria may apply
Exclusion Criteria
Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements
Has a positive drug screen for drugs of abuse at study entry
Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
Additional criteria may apply

Contacts and Locations

Sponsors and CollaboratorsAlkermes, Inc.
Locations
Alkermes Investigational Site | Little Rock Arkansas, United States, 72211Alkermes Investigational Site | Rogers Arkansas, United States, 72758Alkermes Investigational Site | Anaheim California, United States, 92805Alkermes Investigational Site | Cerritos California, United States, 90703Alkermes Investigational Site | Culver City California, United States, 90230Alkermes Investigational Site | Garden Grove California, United States, 92845Alkermes Investigational Site | Glendale California, United States, 91206Alkermes Investigational Site | Long Beach California, United States, 90822Alkermes Investigational Site | Oakland California, United States, 94607Alkermes Investigational Site | Oceanside California, United States, 92056Alkermes Investigational Site | Orange California, United States, 92868Alkermes Investigational Site | Palo Alto California, United States, 94305Alkermes Investigational Site | Pico Rivera California, United States, 90660Alkermes Investigational Site | Redlands California, United States, 92374Alkermes Investigational Site | San Diego California, United States, 92013Alkermes Investigational Site | Temecula California, United States, 92591Alkermes Investigational Site | Torrance California, United States, 90502Alkermes Investigational Site | Lauderhill Florida, United States, 33319Alkermes Investigational Site | North Miami Florida, United States, 33161Alkermes Investigational Site | Atlanta Georgia, United States, 30303Alkermes Investigational Site | Atlanta Georgia, United States, 30329Alkermes Investigational Site | Atlanta Georgia, United States, 30331Alkermes Investigational Site | Augusta Georgia, United States, 30912Alkermes Investigational Site | Decatur Georgia, United States, 30030Alkermes Investigational Site | Chicago Illinois, United States, 60611Alkermes Investigational Site | Chicago Illinois, United States, 60640Alkermes Investigational Site | Winfield Illinois, United States, 60190Alkermes Investigational Site | Grand Rapids Michigan, United States, 49503Alkermes Investigational Site | Flowood Mississippi, United States, 39232Alkermes Investigational Site | Kansas City Missouri, United States, 64108Alkermes Investigational Site | St Louis Missouri, United States, 63110Alkermes Investigational Site | St Louis Missouri, United States, 63118Alkermes Investigational Site | St Louis Missouri, United States, 63128Alkermes Investigational Site | St Louis Missouri, United States, 63141Alkermes Investigational Site | Las Vegas Nevada, United States, 89102Alkermes Investigational Site | Berlin New Jersey, United States, 08009Alkermes Investigational Site | Marlton New Jersey, United States, 08053Alkermes Investigational Site | Brooklyn New York, United States, 11235Alkermes Investigational Site | Rochester New York, United States, 14615Alkermes Investigational Site | Canton Ohio, United States, 44718Alkermes Investigational Site | Cincinnati Ohio, United States, 45219Alkermes Investigational Site | Dayton Ohio, United States, 45417Alkermes Investigational Site | Eugene Oregon, United States, 97401Alkermes Investigational Site | Austin Texas, United States, 78759Alkermes Investigational Site | DeSoto Texas, United States, 75115Alkermes Investigational Site | Fort Worth Texas, United States, 76104Alkermes Investigational Site | Houston Texas, United States, 77030Alkermes Investigational Site | Richardson Texas, United States, 75080Alkermes Investigational Site | Bellevue Washington, United States, 98007Alkermes Investigational Site | Vienna , Austria, Alkermes Investigational Site | Burgas , Bulgaria, Alkermes Investigational Site | Lovech , Bulgaria, Alkermes Investigational Site | Novi Iskar , Bulgaria, Alkermes Investigational Site | Plovdiv , Bulgaria, Alkermes Investigational Site | Sofia , Bulgaria, Alkermes Investigational Site | Tserova Koria , Bulgaria, Alkermes Investigational Site | Veliko Tarnovo , Bulgaria, Alkermes Investigational Site | Vratsa , Bulgaria, Alkermes Investigational Site | Galway , Ireland, Alkermes Investigational Site | Jerusalem , Israel, Alkermes Investigational Site | Ramat Gan , Israel, Alkermes Investigational Site | Brescia , Italy, Alkermes Investigational Site | Naples , Italy, Alkermes Investigational Site | Poznan , Poland, Alkermes Investigational Site | San Juan , Puerto Rico, Alkermes Investigational Site | Arkhangelsk , Russia, Alkermes Investigational Site | Moscow , Russia, Alkermes Investigational Site | Roshchino , Russia, Alkermes Investigational Site | Rostov-on-Don , Russia, Alkermes Investigational Site | Saint Petersburg , Russia, Alkermes Investigational Site | Samara , Russia, Alkermes Investigational Site | Saratov , Russia, Alkermes Investigational Site | Tonnel’nyy , Russia, Alkermes Investigational Site | Belgrade , Serbia, Alkermes Investigational Site | Kragujevac , Serbia, Alkermes Investigational Site | Novi Kneževac , Serbia, Alkermes Investigational Site | Busan , South Korea, 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 | Smila , Ukraine, Alkermes Investigational Site | Vinnytsia , Ukraine, Alkermes Investigational Site | Headington , United Kingdom,
Investigators
Study Director: Alkermes Medical Director, Alkermes, Inc.
Study Documents (Full Text)
Documents provided by Alkermes, Inc.: Study Protocol  May 8, 2019Documents provided by Alkermes, Inc.: Statistical Analysis Plan  June 12, 2023