A long-term extension study has found that daily use of Nuplazid creates sustained, strong reductions in the severity and frequency of delusions and hallucinations in Parkinson’s disease psychosis patients.
The recent trial was an extension of a study which assessed the efficacy and safety of Nuplazid compared to a placebo. That trial involved 199 Parkinson’s psychosis patients. Patients in that trial were randomly received to receive either 34 mg tablets of Nuplazid or placebo tablets, taken once per day for six weeks. That trial found that Nuplazid reduced the severity and frequency of delusions and hallucinations without worsening the motor symptoms of patients.
The recent trial extension involved 178 patients who completed the original trial. 148 of these patients completed the extension study. This trial extension found that use of Nuplazid created durable and strong reductions in the severity and frequency of delusions and hallucinations, as measured by the Scale for the Assessment of Positive Symptoms – Parkinson’s Disease (SAPS-PD). This scale measures inappropriate affect, positive formal thought disorder, bizarre behavior, delusions and hallucinations. A higher score is an indication of more severe psychosis.
These benefits were found in patients who started Nuplazid treatment in the original trial as well as those who only started Nuplazid treatment in the extension study. SAPS-PD scores decreased in people given Nuplazid after having been given a placebo. SAPS-PD scores remained nearly static in those given Nuplazid in the original trial.
Patients were also assessed by the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I) scales. Improvements regarding these scales were also seen, especially in patients who took a placebo before taking Nuplazid. Almost half of these patients felt they had much improved or very much improved by week two of the extension study and more than half felt the same by week four.
Researchers noted the same adverse events they found in the original trial: falls, urinary tract infections, swelling and hallucinations. Most adverse events were of mild to moderate severity. 14 patients had to cease treatment because of side effects.
“Overall, the sustained improvement in the severity of psychotic symptoms was suggested in patients with PDP [Parkinson’s disease psychosis] receiving treatment with pimavanserin 34 mg daily for 10 weeks,” the researchers said.
The trial’s findings were presented at the 2020 American Society of Clinical Psychopharmacology Annual Meeting. The meeting was held virtually because of COVID-19.