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

NCT03201757 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ALK3831-A308
• Study Type: interventional
• Target: 523
• Locations: 13 countries
• Sites: 85

Brief Summary

This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder

Conditions

Schizophrenia; Schizophreniform Disorder; Bipolar I Disorder

Keywords

Alkermes; ALKS 3831; Olanzapine; Samidorphan; Schizophrenia; Schizophreniform; Bipolar I

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  Up to 48 months

• 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

  Up to 48 months

Study Arms (1)

ALKS 3831

EXPERIMENTAL

Coated bilayer tablet

Drug: ALKS 3831

Interventions

ALKS 3831 DRUG

Olanzapine + samidorphan, daily oral dosing

ALKS 3831

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (85)

Alkermes Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Alkermes Investigational Site

Rogers, Arkansas, 72758, United States

Location

Alkermes Investigational Site

Anaheim, California, 92805, United States

Location

Alkermes Investigational Site

Cerritos, California, 90703, United States

Location

Alkermes Investigational Site

Culver City, California, 90230, United States

Location

Alkermes Investigational Site

Garden Grove, California, 92845, United States

Location

Alkermes Investigational Site

Glendale, California, 91206, United States

Location

Alkermes Investigational Site

Long Beach, California, 90822, United States

Location

Alkermes Investigational Site

Oakland, California, 94607, United States

Location

Alkermes Investigational Site

Oceanside, California, 92056, United States

Location

Alkermes Investigational Site

Orange, California, 92868, United States

Location

Alkermes Investigational Site

Palo Alto, California, 94305, United States

Location

Alkermes Investigational Site

Pico Rivera, California, 90660, United States

Location

Alkermes Investigational Site

Redlands, California, 92374, United States

Location

Alkermes Investigational Site

San Diego, California, 92013, United States

Location

Alkermes Investigational Site

Temecula, California, 92591, United States

Location

Alkermes Investigational Site

Torrance, California, 90502, United States

Location

Alkermes Investigational Site

Lauderhill, Florida, 33319, United States

Location

Alkermes Investigational Site

North Miami, Florida, 33161, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30303, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30329, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30331, United States

Location

Alkermes Investigational Site

Augusta, Georgia, 30912, United States

Location

Alkermes Investigational Site

Decatur, Georgia, 30030, United States

Location

Alkermes Investigational Site

Chicago, Illinois, 60611, United States

Location

Alkermes Investigational Site

Chicago, Illinois, 60640, United States

Location

Alkermes Investigational Site

Winfield, Illinois, 60190, United States

Location

Alkermes Investigational Site

Grand Rapids, Michigan, 49503, United States

Location

Alkermes Investigational Site

Flowood, Mississippi, 39232, United States

Location

Alkermes Investigational Site

Kansas City, Missouri, 64108, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63110, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63118, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63128, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63141, United States

Location

Alkermes Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Alkermes Investigational Site

Berlin, New Jersey, 08009, United States

Location

Alkermes Investigational Site

Marlton, New Jersey, 08053, United States

Location

Alkermes Investigational Site

Brooklyn, New York, 11235, United States

Location

Alkermes Investigational Site

Rochester, New York, 14615, United States

Location

Alkermes Investigational Site

Canton, Ohio, 44718, United States

Location

Alkermes Investigational Site

Cincinnati, Ohio, 45219, United States

Location

Alkermes Investigational Site

Dayton, Ohio, 45417, United States

Location

Alkermes Investigational Site

Eugene, Oregon, 97401, United States

Location

Alkermes Investigational Site

Austin, Texas, 78759, United States

Location

Alkermes Investigational Site

DeSoto, Texas, 75115, United States

Location

Alkermes Investigational Site

Fort Worth, Texas, 76104, United States

Location

Alkermes Investigational Site

Houston, Texas, 77030, United States

Location

Alkermes Investigational Site

Richardson, Texas, 75080, United States

Location

Alkermes Investigational Site

Bellevue, Washington, 98007, United States

Location

Alkermes Investigational Site

Vienna, Austria

Location

Alkermes Investigational Site

Burgas, Bulgaria

Location

Alkermes Investigational Site

Lovech, Bulgaria

Location

Alkermes Investigational Site

Novi Iskar, Bulgaria

Location

Alkermes Investigational Site

Plovdiv, Bulgaria

Location

Alkermes Investigational Site

Sofia, Bulgaria

Location

Alkermes Investigational Site

Tserova Koria, Bulgaria

Location

Alkermes Investigational Site

Veliko Tarnovo, Bulgaria

Location

Alkermes Investigational Site

Vratsa, Bulgaria

Location

Alkermes Investigational Site

Galway, Ireland

Location

Alkermes Investigational Site

Jerusalem, Israel

Location

Alkermes Investigational Site

Ramat Gan, Israel

Location

Alkermes Investigational Site

Brescia, Italy

Location

Alkermes Investigational Site

Napoli, Italy

Location

Alkermes Investigational Site

Poznan, Poland

Location

Alkermes Investigational Site

San Juan, Puerto Rico

Location

Alkermes Investigational Site

Arkhangelsk, Russia

Location

Alkermes Investigational Site

Moscow, Russia

Location

Alkermes Investigational Site

Roshchino, Russia

Location

Alkermes Investigational Site

Rostov-on-Don, Russia

Location

Alkermes Investigational Site

Saint Petersburg, Russia

Location

Alkermes Investigational Site

Samara, Russia

Location

Alkermes Investigational Site

Saratov, Russia

Location

Alkermes Investigational Site

Tonnel’nyy, Russia

Location

Alkermes Investigational Site

Belgrade, Serbia

Location

Alkermes Investigational Site

Kragujevac, Serbia

Location

Alkermes Investigational Site

Novi Kneževac, Serbia

Location

Alkermes Investigational Site

Busan, South Korea

Location

Alkermes Investigational Site

Kharkiv, Ukraine

Location

Alkermes Investigational Site

Kherson, Ukraine

Location

Alkermes Investigational Site

Kyiv, Ukraine

Location

Alkermes Investigational Site

Lviv, Ukraine

Location

Alkermes Investigational Site

Poltava, Ukraine

Location

Alkermes Investigational Site

Smila, Ukraine

Location

Alkermes Investigational Site

Vinnytsia, Ukraine

Location

Alkermes Investigational Site

Headington, United Kingdom

Location

Related Publications (1)

• Ballon JS, Kahn RS, Arevalo C, Dunbar M, McDonnell D, Correll CU. Long-Term Safety, Tolerability, and Durability of Treatment Effect of Olanzapine and Samidorphan: Results of a 4-Year Open-Label Study. J Clin Psychiatry. 2024 Dec 4;86(1):24m15511. doi: 10.4088/JCP.24m15511.

  PMID: 39630083 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Global Clinical Services
• Organization: Alkermes

clinicaltrials@alkermes.com

888-253-8008

Study Officials

• Alkermes Medical Director

  Alkermes, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 28, 2017
• Study Start: June 15, 2017
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); KR (1); GB (1); UA (7); PL (1); PR (1); BU (8); RU (8); IL (2); IT (2); AU (1); SE (3); US (49)