Loading clinical trials...

Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients

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)

NCT01495169•Vanda Pharmaceuticals

View on ClinicalTrials.gov

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

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

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.

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

Novartis Investigative Site

Coeur d'Alene, Idaho, United States

Novartis Investigative Site

Baltimore, Maryland, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

Marlton, New Jersey, United States

Novartis Investigative Site

Cincinnati, Ohio, United States

Novartis Investigative Site

Cleveland, Ohio, United States

Novartis Investigative Site

Salt Lake City, Utah, United States

Key Dates

Start Date

October 1, 2011

Primary Completion Date

February 1, 2015

Completion Date

February 1, 2015

Last Updated

June 13, 2016

Enrollment

ACTUAL participants

Conditions

Safety and Tolerability of Iloperidone

Interventions

iloperidone (oral tablet)

DRUG