Zyprexa® Relprevv™ Patient Care Program

Last updated: February 11, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Enrolling

Phase

N/A

Condition

Tourette's Syndrome

Mood Disorders

Schizotypal Personality Disorder (Spd)

Treatment

N/A

Clinical Study ID

NCT01088386
12991
F1D-MC-B041
  • Ages > 18
  • All Genders

Study Summary

The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any patients receiving Zyprexa Relprevv enrolled in Zyprexa Relprevv Patient CareProgram

Exclusion

Exclusion Criteria:

  • Any patient not receiving Zyprexa Relprevv

Study Design

Total Participants: 4000
Study Start date:
March 03, 2010
Estimated Completion Date:
June 30, 2026

Study Description

The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:

  1. Ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;

  2. Informing health care providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified healthcare facilities; and

  3. Establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program registry.

Connect with a study center

  • United BioSource Corporation

    Blue Bell, Pennsylvania 19422
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.