The trial enrolled 423 patients across sites in both the US and Brazil. The primary endpoint of the study was antipsychotic efficacy as measured after day 42 compared to baseline in each of the two ACP-103 co-therapy arms using the Positive and Negative Syndrome Scale (PANSS).
The trial evaluated ACP-103 co-therapy when used together with either Johnson & Johnson’s Risperdal, or haloperidol, a generic typical antipsychotic drug. The co-therapy arms with ACP-103 demonstrated statistically significant antipsychotic efficacy as measured by the reduction in the PANSS, the primary endpoint of the trial.
In addition, the co-therapy arm combining ACP-103 with low-dose Risperdal demonstrated a statistically significant improvement in antipsychotic efficacy as compared to low-dose Risperdal plus placebo, and comparable efficacy to high-dose Risaperdal plus placebo. Co-therapy with ACP-103 also led to a faster onset of antipsychotic action and an improved side effect profile.