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Summary

for people ages 5–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This is a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of RO5285119 in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence quotient [IQ] greater than or equal to [>=] 70). Enrollment will be staggered, starting first with adolescents (aged 13 to 17 years) and then with children (aged 5 to 12 years). Initially, a first cohort of approximately 24 adolescents will be enrolled together. Based on pharmacokinetic evaluation, safety, and tolerability in the first adolescent cohort and determined final doses, enrollment of adolescents will resume and the enrollment of a first cohort of approximately 24 children (aged 5 to 12 years) can commence. Based on acceptable safety and tolerability in the first children cohort and determined final doses, enrollment of children will resume.

Official Title

A Phase II Multi-center, Randomized, Double-blind, 24-Week, 3-Arm, Parallel Group, Placebo-controlled Study to Investigate the Efficacy and Safety of RO5285119 in Children and Adolescents Age 5-17 With Autism Spectrum Disorder (ASD)

Keywords

Autism Spectrum Disorder Disease Autistic Disorder Child Development Disorders, Pervasive

Eligibility

You can join if…

Open to people ages 5–17

  • Fluent in English
  • Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for ASD or International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD10) criteria for Autism diagnosis confirmed by Autism Diagnostic Observational Schedule (ADOS-2) criteria
  • Social Responsiveness Scale, second edition (SRS-2) (T-score) >= 66
  • Clinical Global Impressions of Severity (CGI-S) >= 4 (moderately ill) at screening
  • IQ >= 70 as assessed by Wechsler Abbreviated Scale of Intelligence Scale: Second

Edition (WASI-II) or Wechsler Preschool and Primary Scale of Intelligence: Fourth Edition (WPPSI-IV) intelligence test

  • Language, hearing, and vision compatible with the study measurements as judged by the investigator

You CAN'T join if...

  • Initiation of a major change in psychosocial intervention (including investigational)within 4 weeks prior to screening
  • Unstable or uncontrolled clinically significant psychiatric and/or neurological disorder that may interfere with the safety or efficacy endpoints
  • Known personal or family history of cerebral aneurysm
  • Risk of suicidal behavior
  • Seizure within the past 6 months
  • Medical history of alcohol or substance abuse/dependence
  • Concurrent cardio-vascular disease not considered well controlled by the Investigator
  • Clinically significant abnormality on electrocardiogram at screening
  • Concomitant disease or condition (pulmonary, gastro-intestinal, hepatic, renal,metabolic, immunological system, or obesity that could interfere with the conduct of the study
  • Evidence for current gastro-intestinal bleeding, e.g., active stomach ulcer disease
  • History of coagulopathies, bleeding disorders, or blood dyscrasias
  • Positive serology for hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) 1, or HIV 2
  • Confirmed clinically significant abnormality in parameters of hematology, clinical chemistry, coagulation, or urinalysis
  • Medical history of malignancy if not considered cured
  • Participation in an investigational drug study within 90 days or 5 times the half-life of the investigational molecule (whichever is longer) prior to randomization
  • Loss of blood over 250 milliliters within three months prior to screening
  • Allowed medications have not been stable since 4 weeks before screening, and allowed medications for treatment of epilepsy have not been stable since 3 months before screening
  • Use of prohibited medications within 2 weeks prior to screening visit or 5 times the half-life prior to randomization (whichever is longer)

Locations

  • University of California at San Francisco accepting new patients
    San Francisco, California, 94115, United States
  • PCSD Feighner Research accepting new patients
    San Diego, California, 92108, United States
  • Southwest Autism Research & Resource Center accepting new patients
    Phoenix, Arizona, 85006, United States
  • Zain Research LLC accepting new patients
    Richland, Washington, 99352, United States
  • Northwest Clinical Research Center accepting new patients
    Bellevue, Washington, 98007, United States
  • Seattle Children's Research Institute; Psychiatry and Behavioral Medicine accepting new patients
    Seattle, Washington, 98121, United States
  • Pacific Institute of Medical Sciences accepting new patients
    Bothell, Washington, 98011, United States
  • DBA IMMUNOe Int'l Res Center accepting new patients
    Centennial, Colorado, 80112, United States
  • Children's Hospital of Colorado accepting new patients
    Aurora, Colorado, 80045, United States
  • Cutting Edge Research Group accepting new patients
    Oklahoma City, Oklahoma, 73116, United States
  • Midwest Childrens Health Research Institute accepting new patients
    Lincoln, Nebraska, 68516, United States
  • Road Runner Research accepting new patients
    San Antonio, Texas, 78249, United States
  • Relaro Medical Trials accepting new patients
    Dallas, Texas, 75243, United States
  • BioBehavioral Research of Austin, PC accepting new patients
    Austin, Texas, 78759, United States
  • Red Oak Psychiatry Associates, PA accepting new patients
    Houston, Texas, 77090, United States
  • University of Minnesota; Clin. Neuro Research Unit accepting new patients
    Minneapolis, Minnesota, 55414, United States
  • St. Charles Psychiatric Associates accepting new patients
    Saint Charles, Missouri, 63304, United States
  • Capstone Clinical Research accepting new patients
    Libertyville, Illinois, 60048, United States
  • Rush University Medical Center accepting new patients
    Chicago, Illinois, 60612, United States
  • Vanderbilt University Medical Center accepting new patients
    Nashville, Tennessee, 37232, United States
  • Cincinnati Children's Hospital Medical Center accepting new patients
    Cincinnati, Ohio, 45229, United States
  • Ohio State University accepting new patients
    Columbus, Ohio, 43210, United States
  • Harmonex Neuroscience Research accepting new patients
    Dothan, Alabama, 36303, United States
  • University Hospitals accepting new patients
    Cleveland, Ohio, 44106, United States
  • UPMC Western Psychiatric Institute and Clinic accepting new patients
    Pittsburgh, Pennsylvania, 15203 1101, United States
  • Sarkis Clinical Trials accepting new patients
    Gainesville, Florida, 32607, United States
  • University of South Florida accepting new patients
    Saint Petersburg, Florida, 33701, United States
  • University of Rochester accepting new patients
    Rochester, New York, 14627 0001, United States
  • DUKE SCHOOL OF MEDICINE;Duke Center for Autism and Brain Development accepting new patients
    Durham, North Carolina, 27705, United States
  • Medical Research Group of Central Florida accepting new patients
    Orange City, Florida, 32763, United States
  • APG- Advanced Psychiatric Group accepting new patients
    Orlando, Florida, 32803, United States
  • Suburban Research Associates accepting new patients
    Media, Pennsylvania, 19063, United States
  • Segal trials accepting new patients
    North Miami, Florida, 33161, United States
  • Richmond Behavioral Associates accepting new patients
    Staten Island, New York, 10312, United States
  • Nathan S. Kline Institute for Psychiatric Research accepting new patients
    Orangeburg, New York, 10962, United States
  • Center for Autism and the Developing Brain accepting new patients
    New York, New York, 10032, United States
  • Albert Einstein College of Medicine accepting new patients
    Bronx, New York, 10467, United States
  • Yale University / Yale-New Haven Hospital accepting new patients
    New Haven, Connecticut, 06519-1124, United States
  • UMASS Medical School accepting new patients
    Worcester, Massachusetts, 01655, United States
  • Boston Childrens Hospital accepting new patients
    Boston, Massachusetts, 02115, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02901431
Phase
Phase 2
Study Type
Interventional
Last Updated
March 26, 2018
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