Back to resultsSafety and Tolerability of Open-Labeled Iloperidone in Adolescents
Primary Purpose
Schizophrenia, Bipolar I Disorder
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Iloperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- Vanda Investigational SiteRecruiting
- Vanda Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Iloperidone
Arm Description
Open-label iloperidone
Outcomes
Primary Outcome Measures
Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05648591
Brief Title
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar I Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iloperidone
Arm Type
Experimental
Arm Description
Open-label iloperidone
Intervention Type
Drug
Intervention Name(s)
Iloperidone
Other Intervention Name(s)
VYV-683, FANAPT
Intervention Description
oral tablet
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Email
clinicaltrials@vandapharma.com
Facility Information:
Facility Name
Vanda Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
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