Clinical trial NCT01495169: Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients
Official title: A Multicenter, Open-label, Sequential Cohort, Dose-escalation, 14-day Study to Explore the Tolerability and Pharmacokinetics of Iloperidone 12 to 24 mg/Day Followed by 26 Weeks of Flexible Dosing (6 to 24 mg/Day) in Adolescent Patients (Aged 12 to 17 Years)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety and Tolerability of Iloperidone
Keywords: Antipsychotic
Schizophrenia
Bipolar disorder
Iloperidone
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 33
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication


Eligibility criteria: Inclusion Criteria:

* males or females 12-17 years of age.
* in a stable housing situation with a guardian/parent who can encourage compliance with the study protocol.
* with diagnosis of disorder requiring treatment with an antipsychotic agent.
* having a Children's Global Assessment of Severity Scale (CGAS) of 41 or greater.
* Heart rate \</=100 beats per minute and \>/= 50 beats per minute.

Exclusion Criteria:

* Patients with mild, moderate or severe mental retardation (i.e., documented IQ \<70), do not have the capacity to assent, cannot understand the informed consent, or participate fully in the assessments.
* Hospitalized due to suicidal ideation or suicidal behavior, history of suicidal ideation within 6 months prior to screening, history of suicidal behavior within 2 years prior to screening.
* Pregnant, females who can become pregnant and lactating females.
* Known hypersensitivity to iloperidone and to related drugs.
* Clinical conditions (Neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological), which may pose significant risk to patients or impair reliable study participation.
* Clinically unstable cardiac disease, structural cardiac abnormalities, congential long QT syndrome, clinically significant ECG abnormalities at screening (PR interval \>240 ms, QTcF \>450 ms, QRS duration \>/= 100 ms) or arrhythmias.
* Syncope, near syncope, or palpitations. Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Pharmacokinetics of iloperidone at different dose levels based on AUC (area under the plasma concentration time curve during a dosage interval) Cmax ss (maximum plasma concentration at steady state), Tmax ss (time to Cmax at steady state).
timeFrame: Visit 5, 6, 7 (after at least 7 days of iloperidone treatment at the same dose level)
measure: Tolerability of iloperidone at different dose levels
timeFrame: 14 days
Secondary outcomes:
measure: Number of Patients with Adverse Events, Serious Adverse Events or Death
timeFrame: 26 weeks
measure: Change from baseline in Clinical Global Impression of Improvement Scale (CGI-I)
timeFrame: Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks
measure: Change from baseline in the Children's Global Asessment Scale (CGAS
timeFrame: Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks
measure: Effect of iloperidone on QT, QT beat-to-beat (QTbtb), QT corrected using the Fridericia formulat (QTcF), QT corrected using the Bazett formula (QTcB), individual based correct QT (QTcI)
timeFrame: Baseline (24 hours), Visit 3 (4-hours post initial dose), and Visit 7 (13 hours
measure: Clinically notable changes from baseline on electrocardiogram (ECG) parameters (QTcF, QTcB, QRS, PR, heart rate)
timeFrame: Screening, baseline, 5x over 2 weeks, then every 2-4 weeks for 26 weeks
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Novartis Investigative Site
state: California
city: North Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Coeur d'Alene
country: United States
facility: Novartis Investigative Site
state: Idaho
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Marlton
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: