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

Sumitomo Pharma America, Inc.38 sites in 1 country150 target enrollmentAugust 2013

ConditionsAutism

InterventionsLurasidone 20 mg daily Lurasidone Placebo

DrugsLurasidone 20 mg daily Lurasidone Placebo

Overview

Phase: Phase 3
Intervention: Lurasidone 20 mg daily
Conditions: Autism
Sponsor: Sumitomo Pharma America, Inc.
Enrollment: 150
Locations: 38
Primary Endpoint: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

November 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sumitomo Pharma America, Inc.

Responsible Party

Sponsor

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 ≥
•Screening and Baseline CGI-S ≥
•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:

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.

Arms & Interventions

Lurasidone 20 mg

Lurasidone 20 mg once daily

Intervention: Lurasidone 20 mg daily

Lurasidone 60 mg

Lurasidone 60 mg once daily

Intervention: Lurasidone

Placebo

Placebo once daily

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: Baseline to 6 Weeks

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.

Secondary Outcomes

Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6(Baseline to 6 Weeks)
Change From Baseline in the Caregiver Strain Questionnaire (CGSQ)(6 Weeks)
Change From Baseline in Clinical Global Impression-Severity (CGI-S) 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)
Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score.(6 Weeks)
Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6(6 Weeks)