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NCT05648591 Clinical Trial

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Schizophrenia Clinical Trial

Official title:
Open-label Safety Study of a 1-year 8 to 24 mg/Day Dose Regimen of Iloperidone (FANAPT®) in Adolescent Patients With Schizophrenia or Bipolar I Disorder

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05648591
Other study ID # VP-VYV-683-4101
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 24, 2023
Est. completion date September 2024

Study information
Verified date March 2024
Source Vanda Pharmaceuticals
Contact Vanda Pharmaceuticals Inc.
Phone 202-734-3400
Email clinicaltrials@vandapharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria: - Patient is willing and able to provide assent and willing to complete all aspects of the study - Patient's parent or legal guardian willing and able to provide consent - Male or female patients 12 through 17 years of age (inclusive) - Clinical diagnosis of either schizophrenia or bipolar I disorder Exclusion Criteria: - Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer - A positive test for drugs of abuse

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Iloperidone
oral tablet

Locations
Country Name City State
United States Vanda Investigational Site Atlanta Georgia
United States Vanda Investigational Site Atlanta Georgia
United States Vanda Investigational Site Cincinnati Ohio
United States Vanda Investigational Site Decatur Georgia
United States Vanda Investigational Site DeSoto Texas
United States Vanda Investigational Site Everett Washington
United States Vanda Investigational Site Garfield Heights Ohio
United States Vanda Investigational Site Miami Florida
United States Vanda Investigational Site Saint Louis Missouri
United States Vanda Investigational Site W. Miami Florida
United States Vanda Investigational Site Westlake Ohio

Sponsors (1)
Lead Sponsor Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period. 1 year
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