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Also known as Ralmitaront
RO6889450 · 2 trials · 2 indications
The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.
| Arm | Type | Description |
|---|---|---|
| 150 mg Once Daily (QD) RO6889450 | EXPERIMENTAL | Participants will receive 150 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks. |
| 45 mg QD RO6889450 | EXPERIMENTAL | Participants will receive 45 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive oral placebo QD for 4 weeks. Participants from this arm that continue to the extension period will be randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks or additional 44 weeks (optional 36-Week Safety Extension Phase). |
| 4 mg QD Risperidone | ACTIVE_COMPARATOR | Participants will receive 4 mg of risperidone QD for 4 weeks or 12 weeks or 48 weeks. |
| Sequence 1: Ralmitaront then Placebo | EXPERIMENTAL | Participants were given a daily dose of Ralmitaront during the treatment period of 14 days, followed by a 7 day washout period, and then a daily dose for 14 days with the placebo. |
| Sequence 2: Placebo then Ralmitaront | EXPERIMENTAL | Participants were given a daily dose of the placebo during the 14 day period, followed by a 7 day washout, and then a daily dose of Ralmitaront for 14 days. |
| Name | Type | Description |
|---|---|---|
| RO6889450 | DRUG | Participants will receive oral RO6889450 QD. |
| Placebo | DRUG | Participants will receive oral placebo QD. |
| Risperidone | DRUG | Participants will receive oral risperidone QD. |
| Ralmitaront | DRUG | Participants were given a once 150 mg daily dose of Ralmitaront orally during the 14 day treatment period. |
| Radiolabeled PET tracer [18F]-DOPA | OTHER | \[18 F\]-DOPA solution for injection is manufactured by the PET imaging centers according to specifications established for the tracer at the site. The injection will happen prior to the scan being done and will last for approximately 30 seconds. |
Inclusion criteria * Participant must be 18 to 45 years of age inclusive * Participants with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)...
RO6889450 is an investigational small molecule developed for the treatment of schizophrenia and schizoaffective disorder. It has been studied in patients experiencing an acute exacerbation of these conditions. It is not approved for any indication and remains in clinical development.
RO6889450 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the Phase 2 clinical program evaluating the compound in schizophrenia and schizoaffective disorder.
RO6889450 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
RO6889450 has been evaluated in one completed Phase 2 trial, NCT04512066, titled a trial of the efficacy and safety of RO6889450 versus placebo in patients with an acute exacerbation of schizophrenia or schizoaffective disorder. The trial enrolled 287 patients across the United States, Japan, Russia, and Ukraine.
Yes, RO6889450 is also known as ralmitaront. Both names refer to the same investigational small molecule developed by Roche for schizophrenia and schizoaffective disorder.
The Phase 2 trial NCT04512066 was a randomized, double-blind, placebo-controlled study of RO6889450 in adults aged 18 years and older with an acute exacerbation of schizophrenia or schizoaffective disorder. It enrolled 287 patients and has been completed.