Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Basmisanil · 1 trial · 1 indication
The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB neurocognitive composite T-score is a standardized mean of the six domain scores (excluding social cognition). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher composite T-score represents lower impairment.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. |
| Basmisanil 80mg BID | EXPERIMENTAL | Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks. |
| Basmisanil 240mg BID | EXPERIMENTAL | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Basmisanil | DRUG | Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above. |
| Placebo | DRUG | Participants received matching Placebo to Basmisanil, as per the dosing schedules described above. |
Inclusion Criteria: * Diagnosis of schizophrenia of any type utilizing the Mini International Neuropsychiatric Interview and diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) direct clinical assessments, family informants and past medical records * Evidence of stability o...
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Basmisanil was studied for cognitive impairment associated with schizophrenia in adults already receiving antipsychotic treatment. It is an investigational small molecule developed by Roche and is not an approved treatment. The Phase 2 program enrolled 214 participants with schizophrenia in the United States.
Basmisanil is developed by Roche Holding AG, which trades over the counter in the United States under the ticker RHHBY. Roche sponsored the clinical program evaluating the compound in schizophrenia. No other developer or partner is associated with the asset in the available program information.
Basmisanil is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, placebo-controlled trial that enrolled 214 participants. Basmisanil is investigational and has not been approved for any indication.
Basmisanil was evaluated in trial NCT02953639, titled a study to evaluate the effects of Basmisanil in participants with cognitive impairment associated with schizophrenia treated with antipsychotics. The Phase 2 trial was completed, enrolled 214 participants, and was conducted in the United States with adults aged 18 years and older.
The Basmisanil trial NCT02953639 was a Phase 2, randomized, double-blind, placebo-controlled study. It enrolled 214 adults with cognitive impairment associated with schizophrenia who were receiving antipsychotic treatment. Participants were 18 years or older, both sexes were eligible, and healthy volunteers were not enrolled. The trial has been completed.