A Phase 3 interventional study of ALKS 3831 in Schizophrenia, sponsored by Alkermes, Inc.. Completed at 45 sites in 2 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-07-21.
Sponsored by Alkermes, Inc. · Phase 3, Interventional, and Treatment
The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 266 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Alkermes, Inc. is the lead sponsor of 82 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral tablet, daily dosing
Drug: ALKS 3831
Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Number of Subjects With Adverse Events
Overall summary of treatment emergent adverse events during the treatment period
Time frame: Up to 52 weeks
Subjects that had completed the 24-week treatment period of the antecedent study ALK3831-A303 within seven days prior to enrollment were eligible to be enrolled in the study.
| Milestone | ALKS 3831 |
|---|---|
| Started | 265 |
| Completed | 167 |
| Not completed | 98 |
| Withdrew: Withdrawal by subject | 36 |
| Withdrew: Lost to follow-up | 22 |
| Withdrew: Adverse event | 15 |
| Withdrew: Non-compliance with study drug | 12 |
| Withdrew: Protocol violation | 8 |
| Withdrew: Pregnancy | 2 |
| Withdrew: Incarceration | 1 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Physician decision | 1 |
Overall summary of treatment emergent adverse events during the treatment period
| Participants | ALKS 3831 |
|---|---|
| Any Treatment Emergent Adverse Event (TEAE) | 161 |
| Mild Treatment Emergent Adverse Event (TEAE) | 93 |
| Moderate Treatment- Emergent Adverse Event (TEAE) | 61 |
| Severe Treatment- Emergent Adverse Event (TEAE) | 7 |
| Treatment- Emergent Adverse Event (TEAE)-Not Related | 82 |
| Treatment- Emergent Adverse Event (TEAE)-Related | 79 |
| Adverse Event Leading to Treatment Discontinuation | 15 |
| Any Serious Adverse Event (SAE) | 5 |
| Serious Adverse Event (SAE) -Not Related | 4 |
| Serious Adverse Event (SAE)-Related | 1 |
| Serious Adverse Event (SAE) leading to Death | 0 |
Collected over 52 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ALKS 3831 | 0/265 (0%) | 5/265 (1.9%) | 103/265 (38.9%) |
| Event | ALKS 3831 |
|---|---|
| SchizophreniaPsychiatric disorders | 2/265 |
| Gastritis alcoholicGastrointestinal disorders | 1/265 |
| AgitationPsychiatric disorders | 1/265 |
| Psychotic disorderPsychiatric disorders | 1/265 |
| Acute kidney injuryRenal and urinary disorders | 1/265 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/265 |
| Event | ALKS 3831 |
|---|---|
| Weight decreasedInvestigations | 23/265 |
| Extra dose administeredInjury, poisoning and procedural complications | 21/265 |
| HeadacheNervous system disorders | 18/265 |
| Weight increasedInvestigations | 16/265 |
| Upper respiratory tract infectionInfections and infestations | 12/265 |
| NasopharyngitisInfections and infestations | 10/265 |
| Back painMusculoskeletal and connective tissue disorders | 9/265 |
| Blood creatine phosphokinase increasedInvestigations | 8/265 |
| ToothacheGastrointestinal disorders | 7/265 |
| NauseaGastrointestinal disorders | 6/265 |
| Age, Continuous(years) | ALKS 3831 |
|---|---|
| Mean | 40.7 ± 9.74 |
| Sex: Female, Male(Participants) | ALKS 3831 |
|---|---|
| Female | 73 |
| Male | 192 |
| Ethnicity (NIH/OMB)(Participants) | ALKS 3831 |
|---|---|
| Hispanic or Latino | 40 |
| Not Hispanic or Latino | 225 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | ALKS 3831 |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 187 |
| White | 64 |
| More than one race | 6 |
| Unknown or Not Reported | 3 |
| Height(centimeters) | ALKS 3831 |
|---|---|
| Mean | 173.24 ± 8.992 |
| Weight(kilograms) | ALKS 3831 |
|---|---|
| Mean | 80.64 ± 14.698 |
| Body Mass Index (BMI)(kg/m²) | ALKS 3831 |
|---|---|
| Mean | 26.76 ± 3.756 |
| Body Mass Index (BMI) Group(Participants) | ALKS 3831 |
|---|---|
| Underweight (<18.5) | 1 |
| Normal (18.5 to <25) | 85 |
| Overweight (>=25 to <30) | 121 |
| Obese (>=30) | 58 |
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Alkermes, Inc.