Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

NCT05648591 — Phase 4, Recruiting, 100 participants, Vanda Pharmaceuticals

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

RegistryNCT05648591
StatusRecruiting
PhasePhase 4
Study typeInterventional; na, single group, masking: none, treatment
Enrollment100 (Estimated)
SponsorVanda Pharmaceuticals (Industry)
ConditionsSchizophrenia, Bipolar I Disorder
InterventionsIloperidone (Drug)
Datesstart 2023-05-24, primary completion 2028-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2022-12-13, last updated 2026-10-01
Locations11 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Schizophrenia All trials for Bipolar I Disorder All trials of Iloperidone

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
IloperidoneExperimentalDrug: IloperidoneOpen-label iloperidone
  • Iloperidone (Drug), also known as VYV-683, FANAPT: oral tablet

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 12 Years to 17 Years

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

+Locations (11)

FacilityCityCountryStatus
Vanda Investigational SiteDothan, AlabamaUnited StatesRecruiting
Vanda Investigational SiteLittle Rock, ArkansasUnited StatesRecruiting
Vanda Investigational SiteDenver, ColoradoUnited StatesRecruiting
Vanda Investigational SiteAtlanta, GeorgiaUnited StatesRecruiting
Vanda Investigational SiteAtlanta, GeorgiaUnited StatesRecruiting
Vanda Investigational SiteDecatur, GeorgiaUnited StatesRecruiting
Vanda Investigational SiteKinston, North CarolinaUnited StatesRecruiting
Vanda Investigational SiteCincinnati, OhioUnited StatesRecruiting
Vanda Investigational SiteGarfield Heights, OhioUnited StatesRecruiting
Vanda Investigational SiteWestlake, OhioUnited StatesRecruiting
Vanda Investigational SiteEverett, WashingtonUnited StatesRecruiting