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ALKS 3831 · 7 trials · 5 indications
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
The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug
Overall summary of treatment emergent adverse events during the treatment period
Differences will be compared among treatment groups
| Arm | Type | Description |
|---|---|---|
| ALKS 3831 | EXPERIMENTAL | Coated bilayer tablet |
| Olanzapine | ACTIVE_COMPARATOR | Coated bilayer tablet |
| Placebo | PLACEBO_COMPARATOR | Oral, bilayer tablet |
| Group 1 | EXPERIMENTAL | Olanzapine/samidorphan 10 mg/10 mg |
| Group 2 | EXPERIMENTAL | Olanzapine/samidorphan 20 mg/10 mg |
| Name | Type | Description |
|---|---|---|
| ALKS 3831 | DRUG | Olanzapine + samidorphan, daily oral dosing |
| Olanzapine | DRUG | Daily oral dosing |
| Placebo | DRUG | Daily dosing for 21 consecutive days |
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 f...
ALKS 3831 is an investigational small molecule being studied for the treatment of schizophrenia. It has also been evaluated in healthy volunteers for research purposes. The drug is in clinical development and is not approved by the FDA.
ALKS 3831 is being developed by Alkermes plc, a biopharmaceutical company. Alkermes is publicly traded under the ticker symbol ALKS on the NASDAQ stock exchange.
ALKS 3831 has completed Phase 1, Phase 3, and long-term safety studies. The most advanced completed trials are Phase 3 studies in schizophrenia. The drug remains investigational and is not FDA approved.
ALKS 3831 has been studied in several clinical trials, including NCT02669758, a long-term safety study in adults with schizophrenia, and NCT03187769, a study evaluating its effect on body weight in young adults with schizophrenia or bipolar I disorder. All trials listed are completed.
ALKS 3831 is a small molecule developed for schizophrenia. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its efficacy and safety in treating schizophrenia symptoms.
ALKS 3831 is the primary name used in clinical trials. No alternative names have been reported in the study records. It is an investigational compound distinct from other marketed antipsychotics.