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Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients

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ClinicalTrials.gov Identifier: NCT01495169
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : June 13, 2016
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Safety and Tolerability of Iloperidone Drug: iloperidone (oral tablet) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2011
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Iloperidone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Iloperidone
Part A (dose-escalation and fixed dose): Eligible patients receive iloperidone 2mg/day (1 mg BID) on day 1, then escalated every day for up to 12days utilizing a forced titration regimen to achieve a maximum dose of 12, 16, 20 or 24 mg/day given BID. Part B (optional extension phase): Patients who successfully complete Part A of the study are eligible to continue treatment with iloperidone for an additional 26 weeks
Drug: iloperidone (oral tablet)
iloperidone 12 to 24 mg/day followed by 26 weeks of flexible dosing (6 to 24 mg/day)

Primary Outcome Measures :
  1. 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). [ Time Frame: Visit 5, 6, 7 (after at least 7 days of iloperidone treatment at the same dose level) ]
    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.

  2. Tolerability of iloperidone at different dose levels [ Time Frame: 14 days ]
    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)

Secondary Outcome Measures :
  1. Number of Patients with Adverse Events, Serious Adverse Events or Death [ Time Frame: 26 weeks ]
    Safety and tolerability profile in open-label extension

  2. Change from baseline in Clinical Global Impression of Improvement Scale (CGI-I) [ Time Frame: Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks ]
    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."

  3. Change from baseline in the Children's Global Asessment Scale (CGAS [ Time Frame: Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks ]
    The CGAS) is a numeric scale (1 through 100) used to rate the general functioning of children; high scores indicate better functioning.

  4. 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) [ Time Frame: Baseline (24 hours), Visit 3 (4-hours post initial dose), and Visit 7 (13 hours ]
    Patients wear a holter monitor for ~24 hours during the baseline period, for an additional 4 hours after the first dose, and for ~13 hours after they have been on the same dose for at least 7 days to compare how the heart beats before and after the study drug is taken. The holter monitor transmits continuous data to a computer on how the heart beats for the time when the monitor is on and is a better measurement than data collected by a traditional electrocardiogram (ECG), which provides data on a limited number of heart beats over a short period of time.

  5. Clinically notable changes from baseline on electrocardiogram (ECG) parameters (QTcF, QTcB, QRS, PR, heart rate) [ Time Frame: Screening, baseline, 5x over 2 weeks, then every 2-4 weeks for 26 weeks ]
    Three ECGs are obtained for each assessment. The values are averaged for each ECG parameter (QTcF, QTcB, QRS, PR interval, heart rateare) and clinically notable changes from baseline and new or worsening heart rhythm disorders are identified

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495169

United States, California
Novartis Investigative Site
Costa Mesa, California, United States, 92626
United States, Florida
Novartis Investigative Site
North Miami, Florida, United States, 33161
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30308
United States, Idaho
Novartis Investigative Site
Coeur d'Alene, Idaho, United States, 83814
United States, Maryland
Novartis Investigative Site
Baltimore, Maryland, United States, 21205
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63044
United States, New Jersey
Novartis Investigative Site
Marlton, New Jersey, United States, 08053
United States, Ohio
Novartis Investigative Site
Cincinnati, Ohio, United States, 45219
Novartis Investigative Site
Cleveland, Ohio, United States, 44106-5000
United States, Utah
Novartis Investigative Site
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Vanda Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01495169     History of Changes
Other Study ID Numbers: CILO522D2402
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

Keywords provided by Vanda Pharmaceuticals:
Bipolar disorder