NCT04418466

Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant

Open-Label Study in Stable Schizophrenia Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant (DLP-114)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Delpor, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an Open-Label Study in Stable Schizophrenia Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Risperidone to Risperidone Implant (DLP-114).

Detailed description

Phase 1 open-label study in stable schizophrenia patients designed to evaluate the safety, tolerability, and Pharmacokinetics of switching from 2 mg/day or 3 mg/day oral risperidone to two DLP-114 devices for a six or twelve-month dosing period.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Risperidone	Risperidone Implant

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-02-10
• Completion: 2023-02-10
• First posted: 2020-06-05
• Last updated: 2024-12-27
• Results posted: 2024-12-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study