A 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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Alkermes, Inc.
- Enrollment
- 524
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ALKS 3831
Coated bilayer tablet
Intervention: ALKS 3831 (Drug)
Outcomes
Primary Outcomes
Incidence of Adverse Events
Time Frame: Up to 48 months
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported