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 — DRUGoral 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: IloperidoneOpen-label iloperidone
Primary Outcome Measure
Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period. [ Time Frame: 1 year ]
Central Contacts
- Vanda Pharmaceuticals Inc.202-734-3400
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Vanda Investigational Site | Little Rock | Arkansas | 72204 | 202-734-3400 |
| Vanda Investigational Site | Denver | Colorado | 80202 | 202-734-3400 |
| Vanda Investigational Site | Atlanta | Georgia | 30318 | 202-734-3400 |
| Vanda Investigational Site | Atlanta | Georgia | 30331 | 202-734-3400 |
| Vanda Investigational Site | Decatur | Georgia | 30030 | 202-734-3400 |
| Vanda Investigational Site | Cincinnati | Ohio | 45221 | Vanda Pharmaceuticals 202-734-3400 |
| Vanda Investigational Site | Garfield Heights | Ohio | 44125 | 202-734-3400 |
| Vanda Investigational Site | Westlake | Ohio | 44145 | 202-734-3400 |
| Vanda Investigational Site | Everett | Washington | 98201 | 202-734-3400 |
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