A Study of ALKS 3831 in Adults With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Phase 2, Randomized, Multicenter, Safety, Tolerability, and Dose-Ranging Study of Samidorphan, a Component of ALKS 3831, in Adults With Schizophrenia Treated With Olanzapine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903837
• Other study ID #: ALK3831-302
• Status: Completed
• Phase: Phase 2
• Start date: June 2013
• Est. completion date: March 2015

Study information

• Verified date: September 2021
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 18 to 50 years, inclusive
• Body mass index (BMI) of 17-30 kg/m2, inclusive
• Diagnosis of schizophrenia that is clinically stable

Exclusion Criteria:

• Initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting <2 years
• Current diagnosis of alcohol or drug use disorder, moderate or severe
• Clinically significant or unstable medical illness, condition, or disorder
• Pregnant or breastfeeding
• Significant changes in diet or exercise regimen or plans to join a weight management program during the study
• Opioid medications taken within 14 days and/or need to take opioid medication during the study period
• History of hypersensitivity to or intolerance of olanzapine
• Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week during the past year

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Samidorphan (Low Dose)
Tablets taken once daily
• Samidorphan (Medium Dose)
Tablets taken once daily
• Samidorphan (High Dose)
Tablets taken once daily
• Placebo
Tablets taken once daily
• Olanzapine
Tablets taken once daily

Locations

Country	Name	City	State
Bulgaria	Alkermes Investigational Site	Burgas
Bulgaria	Alkermes Investigational Site	Kazanlak
Bulgaria	Alkermes Investigational Site	Lovech
Bulgaria	Alkermes Investigational Site	Novi Iskar
Bulgaria	Alkermes Investigational Site	Pazardzhik
Bulgaria	Alkermes Investigational Site	Sofia
Bulgaria	Alkermes Investigational Site	Tserova Koria
Bulgaria	Alkermes Investigational Site	Varna
Bulgaria	Alkermes Investigational Site	Vratsa
Czechia	Alkermes Investigational Site	Brno-mesto
Czechia	Alkermes Investigational Site	Praha
United States	Alkermes Investigational Site	Anaheim	California
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	Bellevue	Washington
United States	Alkermes Investigational Site	Bradenton	Florida
United States	Alkermes Investigational Site	Canton	Ohio
United States	Alkermes Investigational Site	Charleston	South Carolina
United States	Alkermes Investigational Site	Chicago	Illinois
United States	Alkermes Investigational Site	Costa Mesa	California
United States	Alkermes Investigational Site	Creve Coeur	Missouri
United States	Alkermes Investigational Site	Culver City	California
United States	Alkermes Investigational Site	Dallas	Texas
United States	Alkermes Investigational Site	Dallas	Texas
United States	Alkermes Investigational Site	Decatur	Georgia
United States	Alkermes Investigational Site	DeSoto	Texas
United States	Alkermes Investigational Site	Escondido	California
United States	Alkermes Investigational Site	Flowood	Mississippi
United States	Alkermes Investigational Site	Fort Lauderdale	Florida
United States	Alkermes Investigational Site	Gainesville	Florida
United States	Alkermes Investigational Site	Garden Grove	California
United States	Alkermes Investigational Site	Houston	Texas
United States	Alkermes Investigational Site	Houston	Texas
United States	Alkermes Investigational Site	Kissimmee	Florida
United States	Alkermes Investigational Site	Lake Charles	Louisiana
United States	Alkermes Investigational Site	Leesburg	Florida
United States	Alkermes Investigational Site	Little Rock	Arkansas
United States	Alkermes Investigational Site	Marlton	New Jersey
United States	Alkermes Investigational Site	Mason	Ohio
United States	Alkermes Investigational Site	Memphis	Tennessee
United States	Alkermes Investigational Site	National City	California
United States	Alkermes Investigational Site	Neptune	New Jersey
United States	Alkermes Investigational Site	New Britain	Connecticut
United States	Alkermes Investigational Site	Oakland	California
United States	Alkermes Investigational Site	Oakland Park	Florida
United States	Alkermes Investigational Site	Oceanside	California
United States	Alkermes Investigational Site	Oklahoma City	Oklahoma
United States	Alkermes Investigational Site	Oklahoma City	Oklahoma
United States	Alkermes Investigational Site	Orange	California
United States	Alkermes Investigational Site	Orlando	Florida
United States	Alkermes Investigational Site	Philadelphia	Pennsylvania
United States	Alkermes Investigational Site	Pico Rivera	California
United States	Alkermes Investigational Site	Richland	Washington
United States	Alkermes Investigational Site	Rockville	Maryland
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	Salt Lake City	Utah
United States	Alkermes Investigational Site	San Diego	California
United States	Alkermes Investigational Site	Shreveport	Louisiana
United States	Alkermes Investigational Site	Torrance	California
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,  Czechia, 

References & Publications (1)

Martin WF, Correll CU, Weiden PJ, Jiang Y, Pathak S, DiPetrillo L, Silverman BL, Ehrich EW. Mitigation of Olanzapine-Induced Weight Gain With Samidorphan, an Opioid Antagonist: A Randomized Double-Blind Phase 2 Study in Patients With Schizophrenia. Am J P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score	Change from baseline (Day 8) to Day 92 (end of study Part A).; The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.	Baseline (Day 8) to Day 92 (end of study Part A)
Secondary	Percent Change in Body Weight (Kilogram) From Baseline to Day 92	Percent change from baseline (Day 8) to the end of Part A (Day 92)	Baseline (Day 8) to Day 92 (end of study Part A)
Secondary	Absolute Change in Body Weight (kg) From Baseline to Day 92	Change from randomization (Day 8) to the end of Part A (Week 12; Day 92)	Baseline (Day 8) to Day 92 (end of study Part A)
Secondary	Percentage of Subjects Exhibiting Significant Weight Gain at Day 92	Significant weight gain will include a >=5%, >= 7%, or >=10% gain in body weight from baseline (Day 8) to Day 92 (end of study Part A)	Baseline (Day 8) to Day 92 (end of study Part A)
Secondary	Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92	Change in CGI-S score from baseline (Day 8) to the end of Part A (Week 12; Day 92).; The CGI-S is a 7-point scale intended to measure the severity of a patient's illness at the time of assessment. Scores range from 1 (normal) to 7(extremely ill), so a higher score is correlative to more severe illness.	Baseline (Day 8) to Day 92 (end of study Part A)