Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients

Vanda Pharmaceuticals33 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Safety and Tolerability of Iloperidone

Interventions

iloperidone (oral tablet)DRUG

iloperidone 12 to 24 mg/day followed by 26 weeks of flexible dosing (6 to 24 mg/day)

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (10)

Novartis Investigative Site

Costa Mesa, California, United States

Novartis Investigative Site

North Miami, Florida, United States

Novartis Investigative Site

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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).

Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing. From the plasma concentration data, AUC, Cmax ss, and Tmax ss are calculated.

Time frame: Visit 5, 6, 7 (after at least 7 days of iloperidone treatment at the same dose level)

Tolerability of iloperidone at different dose levels

Frequency of treatment emergent adverse events, frequency of clinically notable changes from baseline in vital signs, electrocardiograms, laboratory tests, and reponses on movement disorder rating scales (Barnes Akathisia Rating Scale, Simpson-Angus Scale) and on a rating scale for suicidal thoughts and behaviors (Columbia Suicide Severity Rating Scale)

Time frame: 14 days

Secondary Outcomes

Number of Patients with Adverse Events, Serious Adverse Events or Death

Safety and tolerability profile in open-label extension

Time frame: 26 weeks

Change from baseline in Clinical Global Impression of Improvement Scale (CGI-I)

The CGI-I is scored from 1 to 7 and assesses the overall degree of illness relative to baseline. A CGI-I rating of 4 is equivalent to "no change." Ratings less than 4 are equivalent to "improvement" and ratings of more than 4 are equivalent to "worsening."

Time frame: Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks

Change from baseline in the Children's Global Asessment Scale (CGAS

The CGAS) is a numeric scale (1 through 100) used to rate the general functioning of children; high scores indicate better functioning.

Data from ClinicalTrials.gov

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