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Trial record 18 of 40 for:    Developmental Disabilities | ( Map: Oregon, United States )

Lurasidone Pediatric Autism Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01911442
Recruitment Status : Completed
First Posted : July 30, 2013
Results First Posted : February 25, 2016
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Sunovion

Tracking Information
First Submitted Date  ICMJE July 22, 2013
First Posted Date  ICMJE July 30, 2013
Results First Submitted Date  ICMJE November 8, 2015
Results First Posted Date  ICMJE February 25, 2016
Last Update Posted Date February 25, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2013)
Change from Baseline to Week 6 in the ABC irritability subscale [ Time Frame: 6 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
  • Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6 [ Time Frame: Baseline to 6 Weeks ]
    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.
  • Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6 [ Time Frame: Baseline to 6 Weeks ]
    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.
  • Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs) [ Time Frame: 6 Weeks ]
    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.
  • Change From Baseline in the Caregiver Strain Questionnaire (CGSQ) [ Time Frame: 6 Weeks ]
    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.
  • Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6 [ Time Frame: 6 Weeks ]
  • Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score. [ Time Frame: 6 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2013)
  • Change from Baseline in Clinical Global Impression severity (CGI-S) scale [ Time Frame: 6 Weeks ]
  • Change in Clinical Global Impression Improvement (CGI-I) scale [ Time Frame: 6 Weeks ]
  • Change from Baseline in other Aberrant Behavior Checklist (ABC) subscale scores (hyperactivity, stereotypy, inappropriate speech, and lethargy/social withdrawal) [ Time Frame: 6 Weeks ]
  • Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs) [ Time Frame: 6 Weeks ]
  • Change from Baseline in the Caregiver Strain Questionnaire (CGSQ) [ Time Frame: 6 Weeks ]
  • Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6 [ Time Frame: 6 Weeks ]
  • Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score. [ Time Frame: 6 Weeks ]
  • Number of Participants with Adverse Event Reporting [ Time Frame: 6 Weeks ]
  • Laboratory Tests - actual values and change from Baseline values for each time point measured. [ Time Frame: 6 Weeks ]
  • Vital Signs - actual values and change from Baseline values for each time point measured. [ Time Frame: 6 Weeks ]
  • Body Weight-Body Mass Index [ Time Frame: 6 Weeks ]
  • Waist Circumference [ Time Frame: 6 Weeks ]
  • Physical Examination - assessment of general appearance and a review of systems [ Time Frame: 6 Weeks ]
  • Height (as measured by stadiometer) [ Time Frame: 6 Weeks ]
  • Electrocardiogram [ Time Frame: 6 Weeks ]
  • Barnes Akathisia Rating Scale (BARS) [ Time Frame: 6 Weeks ]
  • Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 6 Weeks ]
  • Simpson-Angus Scale (SAS) [ Time Frame: 6 Weeks ]
  • Tanner Staging [ Time Frame: 6 Weeks ]
  • Menstrual Cyclicity - Menstrual cyclicity will be monitored in female subjects who have begun menses. At Baseline, female subjects will be given a calendar to mark the beginning and end of each menses. [ Time Frame: 6 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lurasidone Pediatric Autism Study
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE
  • Drug: Lurasidone 20 mg daily
    Lurasidone 20 mg once daily
    Other Name: Latuda
  • Drug: Lurasidone
    Lurasidone 60 mg once daily
    Other Name: Latuda
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Lurasidone 20 mg
    Lurasidone 20 mg once daily
    Intervention: Drug: Lurasidone 20 mg daily
  • Experimental: Lurasidone 60 mg
    Lurasidone 60 mg once daily
    Intervention: Drug: Lurasidone
  • Placebo Comparator: Placebo
    Placebo once daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2013)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01911442
Other Study ID Numbers  ICMJE D1050325
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunovion
Study Sponsor  ICMJE Sunovion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lurasidone Medical Director, MD Sunovion
PRS Account Sunovion
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP