Safety and Tolerability of IloperidonePhase 1NCT01495169
Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients
A Phase 1 study testing iloperidone (oral tablet) in people with Safety and Tolerability of Iloperidone, run by Vanda Pharmaceuticals at 10 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Safety and Tolerability of Iloperidone
- What is being tested?
- iloperidone (oral tablet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2011to Feb 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Novartis Investigative Site
Atlanta, Georgia, 30308
Novartis Investigative Site
Baltimore, Maryland, 21205
Novartis Investigative Site
Cincinnati, Ohio, 45219
Novartis Investigative Site
Cleveland, Ohio, 44106-5000
Novartis Investigative Site
Coeur d'Alene, Idaho, 83814
Novartis Investigative Site
Costa Mesa, California, 92626
Novartis Investigative Site
Marlton, New Jersey, 08053
Novartis Investigative Site
North Miami, Florida, 33161
Novartis Investigative Site
Salt Lake City, Utah, 84106
Novartis Investigative Site
St Louis, Missouri, 63044
About this study
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)
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
- Conditions
- Safety and Tolerability of Iloperidone
- Being tested
- iloperidone (oral tablet)
- Keywords
- Antipsychotic, Schizophrenia, Bipolar disorder, Iloperidone
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iloperidone (oral tablet)Drug
iloperidone 12 to 24 mg/day followed by 26 weeks of flexible dosing (6 to 24 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Iloperidone | Experimental | 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 Receives: Drug: iloperidone (oral tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 14 days
Secondary outcomes (5)
Number of Patients with Adverse Events, Serious Adverse Events or Death
Safety and tolerability profile in open-label extension
Measured: 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."
Measured: 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.
Measured: Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks
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)
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.
Measured: Baseline (24 hours), Visit 3 (4-hours post initial dose), and Visit 7 (13 hours
Clinically notable changes from baseline on electrocardiogram (ECG) parameters (QTcF, QTcB, QRS, PR, heart rate)
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
Measured: Screening, baseline, 5x over 2 weeks, then every 2-4 weeks for 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Tolerability of IloperidoneStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495169
- Sponsor's protocol ID
- CILO522D2402
- Status last verified
- Jun 2016
- First submitted
- 31 Aug 2011
- Last updated
- 13 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01495169
- Acronym / sponsor ID
- CILO522D2402
- Conditions
- Safety and Tolerability of Iloperidone
- Keywords
- Antipsychotic, Schizophrenia, Bipolar disorder, Iloperidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iloperidone | Experimental | Drug: iloperidone (oral tablet)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 |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iloperidone (oral tablet)iloperidone 12 to 24 mg/day followed by 26 weeks of flexible dosing (6 to 24 mg/day) | Drug | Iloperidone |
Primary outcome
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.
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)
5 secondary outcomes
Number of Patients with Adverse Events, Serious Adverse Events or Death
Time frame: 26 weeks
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
Related trials for Safety and Tolerability of Iloperidone
RecruitingPhase 4
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
Schizophrenia, Bipolar I Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing iloperidone (oral tablet) in people with Safety and Tolerability of Iloperidone, run by Vanda Pharmaceuticals at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: Visit 5, 6, 7 (after at least 7 days of iloperidone treatment at the same dose level)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2016.