Acadia Pharmaceuticals has reported results from a Phase II study that showed that ACP-103 reduced haloperidol-induced akathisia, a debilitating extrapyramidal side-effect, in patients with schizophrenia.
This study is one of two Phase II clinical trials in a program using ACP-103 adjunctively with other antipsychotic drugs to provide an improved therapy for schizophrenia patients. The study involved 34 patients with schizophrenia and was designed to evaluate the ability of ACP-103 to treat akathisia, a side-effect often induced by antipsychotic drugs.
The double-blind, randomized, placebo-controlled study enrolled 34 patients with a clinical diagnosis of schizophrenia or schizoaffective disorder, who also experienced haloperidol-induced akathisia. Results from the study presented in the accompanying table are based on 30 patients who completed the study protocol and exclude four subjects who had major protocol violations. Fourteen of these 30 patients received once-daily oral administration of 60 mg of ACP-103 and 16 were administered placebo over a five-day period.