Lurasidone Pediatric Autism Study

NCT ID: NCT01911442

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-11-30

Brief 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 setting.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lurasidone 20 mg

Lurasidone 20 mg once daily

Group Type: EXPERIMENTAL

Lurasidone 20 mg daily

Intervention Type: DRUG

Lurasidone 20 mg once daily

Lurasidone 60 mg

Lurasidone 60 mg once daily

Group Type: EXPERIMENTAL

Lurasidone

Intervention Type: DRUG

Lurasidone 60 mg once daily

Placebo

Placebo once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Lurasidone 20 mg daily

Lurasidone 20 mg once daily

Intervention Type: DRUG

Lurasidone

Lurasidone 60 mg once daily

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Latuda; Latuda

Eligibility Criteria

Inclusion Criteria

• 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.
• 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

1. 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.

Exclusion Criteria

• 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.
• 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:

1. 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).

2. 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lurasidone Medical Director, MD

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

Harmonex Neuroscience Research

Dothan, Alabama, United States

Southwest Autism Research & Resource Center

Phoenix, Arizona, United States

Newport Beach Clinical Research Associates

Newport Beach, California, United States

University of California San Francisco Medical Center

San Francisco, California, United States

Florida Clinical Research Center, LLC

Bradenton, Florida, United States

Sarkis Clinical Trials - Parent

Gainesville, Florida, United States

Palm Springs Research Institute Inc

Hialeah, Florida, United States

Florida Clinical Research Center, LLC

Maitland, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Medical Research Group of Central Florida

Sanford, Florida, United States

University of South Florida

St. Petersburg, Florida, United States

University of South Florida

Tampa, Florida, United States

Institute for Behavioral Medicine, LLC

Smyrna, Georgia, United States

Capstone Clinical Research, Inc.

Libertyville, Illinois, United States

Baber Research Group

Naperville, Illinois, United States

University of Kentucky

Lexington, Kentucky, United States

Lake Charles Clinical Trials, LLC

Lake Charles, Louisiana, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

NeuroScientific Insights

Rockville, Maryland, United States

Neurobehaviorial Medicine Group, PLLC

Bloomfield Hills, Michigan, United States

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Childrens Specialized Hospital

Toms River, New Jersey, United States

Finger Lakes Clinical Research

Rochester, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Montefiore Medical Center PRIME

The Bronx, New York, United States

Chapel Hill Neurology

Chapel Hill, North Carolina, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

The Ohio State University Nisonger Center

Columbus, Ohio, United States

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Cyn3rgy Research & Development

Gresham, Oregon, United States

Suburban Research Associates

Media, Pennsylvania, United States

Segal Institute for Clinical Research

Charleston, South Carolina, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Family Psychiatry of The Woodlands, P.A.

The Woodlands, Texas, United States

Ericksen Research & Development, LLC

Clinton, Utah, United States

CRI Lifetree

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Neuroscience, Inc.

Herndon, Virginia, United States

Carilion Clinic

Roanake, Virginia, United States

Pacific Institute of Medical Sciences

Bothell, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37811711 (View on PubMed)

Other Identifiers

D1050325

Identifier Type: -

Identifier Source: org_study_id