NCT02773576

Safety and Tolerability of Risperidone Implants

A One Year, Open-label, Study to Evaluate the Safety and Tolerability of Risperidone Implants as a Maintenance Treatment in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Braeburn Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A one year, open-label, study to evaluate the safety and tolerability of risperidone implants as a maintenance treatment in patients with schizophrenia

Detailed description

The trial is to evaluate the 48-week safety and tolerability of risperidone implants as maintenance therapy in subjects with schizophrenia. This will be measured by the incidence of psychotic symptoms exacerbation/impending relapse, PANSS, CGI-I, CGI-S, adverse events, vital signs, clinical laboratory, physical exam and ECG findings, Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson-Angus Scale (SAS) and Investigator assessments.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Risperidone implant

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2016-05-16
• Last updated: 2020-02-19
• Results posted: 2020-02-19

Locations

1 site across 1 country: United States