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AutismPhase 3NCT01911442

Lurasidone Pediatric Autism Study

A Phase 3 study testing Lurasidone 20 mg daily and Lurasidone in people with Autism, run by Sumitomo Pharma America, Inc. at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community… Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Autism
What is being tested?
Lurasidone 20 mg daily and Lurasidone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
41 sitesUnited States
Study dates
Aug 2013to Nov 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' adherence to the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) requirements, the subject will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
  • Male or female subjects 6 to 17 years of age, inclusive, at the time of consent.
  • A reliable informant (eg, parent, legal guardian, or caregiver) who has past and current direct knowledge of the subject must accompany the subject at each visit and must oversee the administration of the study drug.
  • DSM-IV-TR primary diagnosis of autistic disorder confirmation of the diagnosis by a trained clinician (eg, psychiatrist, psychologist, social workers, etc) at the time of screening, by means of the Autism Diagnostic Interview, Revised (ADI-R).
  • Screening and Baseline ABC irritability subscale score ≥ 18.
  • Screening and Baseline CGI-S ≥ 4.
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  • Within 5th to 95th percentile for gender specific Growth Charts from Centers for Disease Control (CDC).
  • No clinically relevant abnormal laboratory values.
  • No clinically relevant abnormal vital sign values/findings
  • Females who participate in this study:
  • are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR-
  • practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken;
  • -OR-
  • •are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.
  • Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.
  • In the judgment of the investigator, the subject is able to swallow the size and number of study drug tablets specified per protocol (See Table 4 for study drug tablet size).
  • Able to adhere to protocol-specified meal requirements during dosing.
  • Have a stable living arrangement for at least 3 months prior to screening.
  • Non-pharmacologic therapy (eg, behavior modification) must be stable for at least 4 weeks before screening and consistent throughout the study.

Who cannot join

  • Subjects with profound intellectual disability.
  • Current diagnosis of bipolar disorder, psychosis, schizophrenia or major depression, or childhood disintegrative disorder as confirmed by the MINI-Kid (as appropriate) at screening. Confirmed genetic disorders with cognitive and behavioral disturbances are also exclusionary.
  • Clinically significant neurological, metabolic (including type 1 and type 2 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study.
  • Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during screening.
  • Evidence of any chronic organic disease of the CNS such as tumors, inflammation, active seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood- eg, Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders. In addition, subjects must not have a history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary.
  • If the subject has a history of seizures, the subjects must not currently be taking any antiepileptic drugs (AEDs) and be seizure-free for at least 6 months.
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  • Clinically significant finding(s) on physical examination determined by the investigator to pose a health concern to the subject while on study.
  • A history or presence of abnormal ECG, which in the investigator's opinion is clinically significant. Screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read.
  • Known history or presence of clinically significant intolerance to any antipsychotic medications including but not limited to angioedema, serotonin or neuroleptic malignant syndromes, severe dystonia, or moderate to severe tardive dyskinesia.
  • Clinically significant alcohol abuse/dependence or drug abuse/dependence based on Mini International Neuropsychiatric Interview for children and adolescents (MINI-Kid) criteria within the last 6 months prior to screening.
  • Clinically significant orthostatic hypotension (ie, a drop in systolic blood pressure of 20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 4 minutes of standing up).
  • Presence or history (within the last year) of a medical or surgical condition (eg, gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
  • Positive test results at screening for:
  • Urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, cannabinoids, methamphetamine, and methadone). However, a positive test for amphetamines, barbiturates, opiates, benzodiazepines or methadone may not result in exclusion of subjects if the investigator determines that the positive test is as a result of prescription medicine(s).
  • Pregnancy test (only in female subjects ≥ 11 years old).
  • Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS), or history of Hepatitis B or C.
  • Participated in another interventional clinical trial or receiving an investigational product within 30 days prior to study drug administration.
  • Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to randomization.
  • Received depot neuroleptics unless the last injection was at least 1 month or 1 treatment cycle prior to screening, whichever is longer.
  • Subject has received treatment with antidepressants within 3 days, fluoxetine hydrochloride at any time within 21 days, an MAO inhibitor within 21 days of randomization or clozapine within 120 days of randomization. Depot neuroleptics must be discontinued at least one treatment cycle prior to randomization.
  • Use of any antipsychotic medication (other than study drug), carbamazepine, oxcarbazepine or fluvoxamine, within 3 days prior to randomization.
  • Females who are pregnant, lactating, or likely to become pregnant during the study.
  • Donation of whole blood within 60 days prior to randomization.
  • Has a prolactin concentration greater than or equal to 100 ng/mL at screening.
  • Subject is considered by the investigator to be at imminent risk of suicide during the study. Subject has a history of one or more serious suicide attempts (based on the investigator's judgment) in the 12 months prior to screening. Subjects determined to be at risk of suicide or injury, as assessed by the investigator at screening, will be referred for further psychiatric evaluation.
  • Clinically relevant history of drug hypersensitivity to lurasidone or any components in the formulation.
  • Subject requires use of concomitant medications that are potent inducers or inhibitors of the cytochrome P450 (CYP) 3A4 enzyme system (Appendix C) from signing informed consent until follow-up.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21287

  • Neurobehaviorial Medicine Group, PLLC

    Bloomfield Hills, Michigan, 48302

  • Pacific Institute of Medical Sciences

    Bothell, Washington, 98011

  • Florida Clinical Research Center, LLC

    Bradenton, Florida, 34201

  • Chapel Hill Neurology

    Chapel Hill, North Carolina, 27517

  • Segal Institute for Clinical Research

    Charleston, South Carolina, 29407

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Ericksen Research & Development, LLC

    Clinton, Utah, 84015

  • The Ohio State University Nisonger Center

    Columbus, Ohio, 43210

  • Harmonex Neuroscience Research

    Dothan, Alabama, 36303

  • Sarkis Clinical Trials - Parent

    Gainesville, Florida, 32607

  • Cyn3rgy Research & Development

    Gresham, Oregon, 97030

  • Neuroscience, Inc.

    Herndon, Virginia, 20170

  • Palm Springs Research Institute Inc

    Hialeah, Florida, 33012

  • Lake Charles Clinical Trials, LLC

    Lake Charles, Louisiana, 70629

  • Center for Psychiatry and Behavioral Medicine, Inc.

    Las Vegas, Nevada, 89128

  • University of Kentucky

    Lexington, Kentucky, 40509

  • Capstone Clinical Research, Inc.

    Libertyville, Illinois, 60048

  • Florida Clinical Research Center, LLC

    Maitland, Florida, 32751

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Baber Research Group

    Naperville, Illinois, 60563

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Newport Beach Clinical Research Associates

    Newport Beach, California, 92663

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806

  • Southwest Autism Research & Resource Center

    Phoenix, Arizona, 85006

  • Carilion Clinic

    Roanake, Virginia, 24014

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • NeuroScientific Insights

    Rockville, Maryland, 20852

  • CRI Lifetree

    Salt Lake City, Utah, 84106

  • University of California San Francisco Medical Center

    San Francisco, California, 94143

  • Medical Research Group of Central Florida

    Sanford, Florida, 32771

  • Institute for Behavioral Medicine, LLC

    Smyrna, Georgia, 30080

  • University of South Florida

    St. Petersburg, Florida, 33701

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • University of South Florida

    Tampa, Florida, 33613-4706

  • Montefiore Medical Center PRIME

    The Bronx, New York, 10467

  • Family Psychiatry of The Woodlands, P.A.

    The Woodlands, Texas, 77381

  • Childrens Specialized Hospital

    Toms River, New Jersey, 08755

Other trials in United States

About this study

Official title: A 6-Week, Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Irritability Associated With Autistic Disorder

This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.

Read the detailed description

This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.

Conditions
Autism
Being tested
Lurasidone 20 mg daily, Lurasidone, Placebo
Keywords
Autism, Lurasidone, Latuda
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lurasidone 20 mg dailyDrug

    Also called Latuda

    Lurasidone 20 mg once daily

  • LurasidoneDrug

    Also called Latuda

    Lurasidone 60 mg once daily

  • PlaceboDrug

    Placebo

Study groups in NCT01911442
Study groupRoleWhat they receive
Lurasidone 20 mgExperimentalLurasidone 20 mg once daily
Receives: Drug: Lurasidone 20 mg daily
Lurasidone 60 mgExperimentalLurasidone 60 mg once daily
Receives: Drug: Lurasidone
PlaceboPlacebo comparatorPlacebo once daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6

    The ABC irritability subscale score is the sum of 15 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC irritability subscale score ranges from 0 to 45. Higher values of ABC subscale scores represent greater severity of illness.

    Measured: Baseline to 6 Weeks

Secondary outcomes (6)

  1. Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6

    The Clinical Global Impression - Severity of Illness (CGI-S) Scale is rated on a 7-point scale of severity with 1 = Normal, not at all ill to 7 = Among the most extremely ill patients. Higher values of CGI-S scores represent greater severity of illness.

    Measured: Baseline to 6 Weeks

  2. Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6

    The ABC hyperactivity and noncompliance subscale score is the sum of 16 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC hyperactivity and noncompliance subscale score may range from 0 to 48. In general, higher values of ABC subscale scores represent greater severity of illness.

    Measured: Baseline to 6 Weeks

  3. Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs)

    CY-BOCS total score ranges from 0 to 20. The higher value of CY-BOCS scores the greater severity of illness. This table is a summary of Y-BOCS compulsion total score.

    Measured: 6 Weeks

  4. Change From Baseline in the Caregiver Strain Questionnaire (CGSQ)

    CGSQ is a caregiver reported assessment to assesses extent to which caregivers are affected by special demands associated with caring for a child with emotional/behavioral problems. CGSQ is comprised of three subscales which range in severity from 1 to 5 (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain), The 3 subscales are calculated as the averages of the corresponding individual items. Higher scores on each indicates greater strain. A Global Strain score is calculated by summing the three subscales (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain) to provide an indication of the total impact of the special demands on the family. Global Strain scores range from 3 to 15. As with the individual subscales, higher scores indicate greater strain.

    Measured: 6 Weeks

  5. Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6

    Measured: 6 Weeks

  6. Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score.

    Measured: 6 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01911442
Sponsor's protocol ID
D1050325
Status last verified
Jan 2016
First submitted
22 Jul 2013
Last updated
25 Feb 2016
Data monitoring committee
Yes

Publications

  • Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

    PubMed 37811711

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lurasidone 20 mg daily and Lurasidone in people with Autism, run by Sumitomo Pharma America, Inc. at 41 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 19 inclusion and 27 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 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6 (time frame: Baseline to 6 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01911442, which also lists 1 linked publication.

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 25 Feb 2016.

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