Lurasidone Pediatric Autism Study
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
1 other identifier
interventional
150
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2013
Shorter than P25 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2013
CompletedFirst Posted
Study publicly available on registry
July 30, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
February 25, 2016
CompletedFebruary 25, 2016
January 1, 2016
1.3 years
July 22, 2013
November 8, 2015
January 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline to 6 Weeks
Secondary Outcomes (6)
Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6
Baseline to 6 Weeks
Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6
Baseline to 6 Weeks
Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs)
6 Weeks
Change From Baseline in the Caregiver Strain Questionnaire (CGSQ)
6 Weeks
Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6
6 Weeks
- +1 more secondary outcomes
Study Arms (3)
Lurasidone 20 mg
EXPERIMENTALLurasidone 20 mg once daily
Lurasidone 60 mg
EXPERIMENTALLurasidone 60 mg once daily
Placebo
PLACEBO COMPARATORPlacebo once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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.
- +4 more criteria
You may not qualify if:
- Subjects with profound intellectual disability.
- 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.
- 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:
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Harmonex Neuroscience Research
Dothan, Alabama, 36303, United States
Southwest Autism Research & Resource Center
Phoenix, Arizona, 85006, United States
Newport Beach Clinical Research Associates
Newport Beach, California, 92663, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201, United States
Sarkis Clinical Trials - Parent
Gainesville, Florida, 32607, United States
Palm Springs Research Institute Inc
Hialeah, Florida, 33012, United States
Florida Clinical Research Center, LLC
Maitland, Florida, 32751, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Medical Research Group of Central Florida
Sanford, Florida, 32771, United States
University of South Florida
St. Petersburg, Florida, 33701, United States
University of South Florida
Tampa, Florida, 33613-4706, United States
Institute for Behavioral Medicine, LLC
Smyrna, Georgia, 30080, United States
Capstone Clinical Research, Inc.
Libertyville, Illinois, 60048, United States
Baber Research Group
Naperville, Illinois, 60563, United States
University of Kentucky
Lexington, Kentucky, 40509, United States
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, 70629, United States
Kennedy Krieger Institute
Baltimore, Maryland, 21287, United States
NeuroScientific Insights
Rockville, Maryland, 20852, United States
Neurobehaviorial Medicine Group, PLLC
Bloomfield Hills, Michigan, 48302, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Childrens Specialized Hospital
Toms River, New Jersey, 08755, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Montefiore Medical Center PRIME
The Bronx, New York, 10467, United States
Chapel Hill Neurology
Chapel Hill, North Carolina, 27517, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University Nisonger Center
Columbus, Ohio, 43210, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Cyn3rgy Research & Development
Gresham, Oregon, 97030, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Segal Institute for Clinical Research
Charleston, South Carolina, 29407, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Family Psychiatry of The Woodlands, P.A.
The Woodlands, Texas, 77381, United States
Ericksen Research & Development, LLC
Clinton, Utah, 84015, United States
CRI Lifetree
Salt Lake City, Utah, 84106, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Neuroscience, Inc.
Herndon, Virginia, 20170, United States
Carilion Clinic
Roanake, Virginia, 24014, United States
Pacific Institute of Medical Sciences
Bothell, Washington, 98011, United States
Related Publications (1)
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.
PMID: 37811711DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- 1-866-503-6351
- Organization
- Sunovion
Study Officials
- STUDY DIRECTOR
Lurasidone Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2013
First Posted
July 30, 2013
Study Start
August 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
February 25, 2016
Results First Posted
February 25, 2016
Record last verified: 2016-01