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Basmisanil · 2 trials · 2 indications
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. |
| Basmisanil in Japanese Healthy Volunteers | EXPERIMENTAL | Japanese healthy volunteers will receive a single oral dose of RO5186582 within 15 minutes after completing a standard meal. |
| 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...
Basmisanil is an investigational small molecule being developed by Roche Holding AG (RHHBY). It has been studied in healthy volunteers and in patients with cognitive impairment associated with schizophrenia. The drug is currently in clinical development and is not approved by the FDA.
Basmisanil has been studied for use in healthy volunteers and in participants with cognitive impairment associated with schizophrenia (CIAS) who are treated with antipsychotics. Its development has focused on these conditions, with clinical trials completed in both areas.
Basmisanil is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the pharmaceutical company responsible for advancing this investigational small molecule through clinical research.
Basmisanil has completed a Phase 1 study in healthy volunteers and a Phase 2 study in schizophrenia patients. The drug is investigational and remains in clinical development, with no FDA approval granted.
Basmisanil has been studied in two completed trials. NCT02534207 was a Phase 1 positron emission tomography study in Japanese healthy volunteers in the United Kingdom. NCT02953639 was a Phase 2 study evaluating effects in participants with cognitive impairment associated with schizophrenia in the United States.
Basmisanil is the primary name for this investigational drug. No alternative names have been reported in the clinical trial data, so it is not known to be the same as any other drug under a different name.