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

Phase 3

Completed

• Conditions: Bipolar I Disorder; Schizophrenia; Schizophreniform Disorder
• Interventions: Drug: ALKS 3831

• Registration Number: NCT03201757
• Lead Sponsor: Alkermes, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-15
• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-28
• Primary Completion: 2023-09-06
• Study Completion: 2023-09-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 524

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALKS 3831	ALKS 3831	Coated bilayer tablet

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	Up to 48 months
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	Up to 48 months	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

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇬🇧 Headington, United Kingdom