Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Vanda Pharmaceuticals
Study ID
NCT05648591
Phase
PHASE4
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Iloperidone — DRUG
    oral tablet

Study Details

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

Key Dates

Start date
May 24, 2023
Status verified
Feb 2025
Primary completion
Mar 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Iloperidone
    Open-label iloperidone

Primary Outcome Measure

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

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Vanda Investigational SiteLittle RockArkansas72204
202-734-3400
Vanda Investigational SiteDenverColorado80202
202-734-3400
Vanda Investigational SiteAtlantaGeorgia30318
202-734-3400
Vanda Investigational SiteAtlantaGeorgia30331
202-734-3400
Vanda Investigational SiteDecaturGeorgia30030
202-734-3400
Vanda Investigational SiteCincinnatiOhio45221
Vanda Pharmaceuticals
202-734-3400
Vanda Investigational SiteGarfield HeightsOhio44125
202-734-3400
Vanda Investigational SiteWestlakeOhio44145
202-734-3400
Vanda Investigational SiteEverettWashington98201
202-734-3400

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