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

NCT04418466 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-12-27

Study results available
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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).

Conditions

Interventions

COMBINATION_PRODUCT

Risperidone

Risperidone Implant

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Delpor, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-02-10
Completion
2023-02-10
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04418466 on ClinicalTrials.gov