NCT02411526

Safety and PK Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Stable Schizophrenia

An Open-Label, Multiple Dose, Safety and Pharmacokinetic Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Patients With Chronic, Stable Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Zogenix, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multiple dose, PK and safety study in patients with chronic, stable schizophrenia or schizoaffective disorder.

Detailed description

Approximately 75 male and female patients with schizophrenia or schizoaffective disorder on antipsychotic maintenance medication will be enrolled into the study. There will be 4 planned cohorts of 14 patients per cohort. In Cohorts 1-3, patients' planned participation in the study is for a total of approximately 22 weeks, including a Screening period of up to 35 days, and a study treatment period of 120 days (including follow-up). In Cohort 4 planned participation in the study is for a total of approximately 18 weeks including a Screening period of up to 35 days and a study treatment of 92 days (including follow-up).

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	ZX003 (Risperidone-SABER®)	ZX003 administered as a SC injection
DRUG	Risperdal Consta	Risperdal Consta administered as a IM injection
DRUG	Oral Risperidone	Oral Risperidone given to ensure adequate therapeutic plasma concentrations from Risperdal Consta

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-04-08
• Last updated: 2022-10-31

Locations

1 site across 1 country: United States