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Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Sponsor
Vanda Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05648591
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
21
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Iloperidone

Open-label iloperidone

Drug: Iloperidone
oral tablet
Other Names:
  • VYV-683
  • FANAPT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanda Investigational Site DeSoto Texas United States 75115

    Sponsors and Collaborators

    • Vanda Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vanda Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05648591
    Other Study ID Numbers:
    • VP-VYV-683-4101
    First Posted:
    Dec 13, 2022
    Last Update Posted:
    Dec 13, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Schizophrenia
    Iloperidone

    Study Results

    No Results Posted as of Dec 13, 2022