A Study to Investigate the Efficacy and Safety of RO5285119 in Participants With Autism Spectrum Disorder (ASD)

Description

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.

Study Start Date

November, 21 2016

Estimated Completion Date

April 2019

Interventions

  • Drug: Placebo
  • Drug: RO5285119

Study ID

Hoffmann-La Roche -- BP30153

Status

Recruiting

Trial ID

NCT02901431

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

300

Sponsor

Hoffmann-La Roche

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Gender

All

Ages

5 Years to 17 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (87)

Study Location Distance Name Phone Email
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
UMASS Medical School - Worcester, Massachusetts 34.2 miles None None None
UMASS Medical School - Worcester, Massachusetts 34.2 miles None None None
UMASS Medical School - Worcester, Massachusetts 34.2 miles None None None
Nathan S Kline Institute for Psychiatric Research - Orangeburg, New York 173.9 miles None None None
Nathan S Kline Institute for Psychiatric Research - Orangeburg, New York 173.9 miles None None None
Nathan S Kline Institute for Psychiatric Research - Orangeburg, New York 173.9 miles None None None
Albert Einstein College of Medicine - The Bronx, New York 176.6 miles None None None
Albert Einstein College of Medicine - The Bronx, New York 176.6 miles None None None
Albert Einstein College of Medicine - The Bronx, New York 176.6 miles None None None
Richmond Behavioral Associates - Staten Island, New York 203.5 miles None None None
Richmond Behavioral Associates - Staten Island, New York 203.5 miles None None None
Richmond Behavioral Associates - Staten Island, New York 203.5 miles None None None
Suburban Research Associates - Media, Pennsylvania 281.7 miles None None None
Suburban Research Associates - Media, Pennsylvania 281.7 miles None None None
Suburban Research Associates - Media, Pennsylvania 281.7 miles None None None
University Hospitals - Cleveland, Ohio 544.0 miles None None None
University Hospitals - Cleveland, Ohio 544.0 miles None None None
DUKE SCHOOL OF MEDICINEDuke Center for Autism and Brain Development - Durham, North Carolina 608.4 miles None None None
DUKE SCHOOL OF MEDICINEDuke Center for Autism and Brain Development - Durham, North Carolina 608.4 miles None None None
DUKE SCHOOL OF MEDICINEDuke Center for Autism and Brain Development - Durham, North Carolina 608.4 miles None None None
Ohio State University - Columbus, Ohio 641.8 miles None None None
Ohio State University - Columbus, Ohio 641.8 miles None None None
Ohio State University - Columbus, Ohio 641.8 miles None None None
Rush University Medical Center - Chicago, Illinois 851.3 miles None None None
Rush University Medical Center - Chicago, Illinois 851.3 miles None None None
Rush University Medical Center - Chicago, Illinois 851.3 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles None None None
Sarkis Clinical Trials - Gainesville, Florida 1,083.3 miles None None None
Sarkis Clinical Trials - Gainesville, Florida 1,083.3 miles None None None
Sarkis Clinical Trials - Gainesville, Florida 1,083.3 miles None None None
Medical Research Group of Central Florida - Orange City, Florida 1,090.5 miles None None None
Medical Research Group of Central Florida - Orange City, Florida 1,090.5 miles None None None
Medical Research Group of Central Florida - Orange City, Florida 1,090.5 miles None None None
Harmonex Neuroscience Research - Dothan, Alabama 1,102.1 miles None None None
APG Advanced Psychiatric Group - Orlando, Florida 1,115.8 miles None None None
APG Advanced Psychiatric Group - Orlando, Florida 1,115.8 miles None None None
APG Advanced Psychiatric Group - Orlando, Florida 1,115.8 miles None None None
University of Minnesota Clin Neuro Research Unit - Minneapolis, Minnesota 1,119.5 miles None None None
University of Minnesota Clin Neuro Research Unit - Minneapolis, Minnesota 1,119.5 miles None None None
University of Minnesota Clin Neuro Research Unit - Minneapolis, Minnesota 1,119.5 miles None None None
University of South Florida - Saint Petersburg, Florida 1,201.6 miles None None None
University of South Florida - Saint Petersburg, Florida 1,201.6 miles None None None
University of South Florida - Saint Petersburg, Florida 1,201.6 miles None None None
Midwest Childrens Health Research Institute - Lincoln, Nebraska 1,323.8 miles None None None
Midwest Childrens Health Research Institute - Lincoln, Nebraska 1,323.8 miles None None None
Midwest Childrens Health Research Institute - Lincoln, Nebraska 1,323.8 miles None None None
Cutting Edge Research Group - Oklahoma City, Oklahoma 1,494.1 miles None None None
Cutting Edge Research Group - Oklahoma City, Oklahoma 1,494.1 miles None None None
Cutting Edge Research Group - Oklahoma City, Oklahoma 1,494.1 miles None None None
Relaro Medical Trials - Dallas, Texas 1,542.9 miles None None None
Relaro Medical Trials - Dallas, Texas 1,542.9 miles None None None
Relaro Medical Trials - Dallas, Texas 1,542.9 miles None None None
Red Oak Psychiatry Associates PA - Houston, Texas 1,598.9 miles None None None
Red Oak Psychiatry Associates PA - Houston, Texas 1,598.9 miles None None None
Red Oak Psychiatry Associates PA - Houston, Texas 1,598.9 miles None None None
BioBehavioral Research of Austin PC - Austin, Texas 1,691.4 miles None None None
BioBehavioral Research of Austin PC - Austin, Texas 1,691.4 miles None None None
BioBehavioral Research of Austin PC - Austin, Texas 1,691.4 miles None None None
DBA IMMUNOe Intl Res Center - Centennial, Colorado 1,764.5 miles None None None
DBA IMMUNOe Intl Res Center - Centennial, Colorado 1,764.5 miles None None None
DBA IMMUNOe Intl Res Center - Centennial, Colorado 1,764.5 miles None None None
Road Runner Research - San Antonio, Texas 1,767.0 miles None None None
Road Runner Research - San Antonio, Texas 1,767.0 miles None None None
Road Runner Research - San Antonio, Texas 1,767.0 miles None None None
Southwest Autism Research Resource Center - Phoenix, Arizona 2,296.9 miles None None None
Southwest Autism Research Resource Center - Phoenix, Arizona 2,296.9 miles None None None
Southwest Autism Research Resource Center - Phoenix, Arizona 2,296.9 miles None None None
Zain Research LLC - Richland, Washington 2,366.7 miles None None None
Zain Research LLC - Richland, Washington 2,366.7 miles None None None
Zain Research LLC - Richland, Washington 2,366.7 miles None None None
Northwest Clinical Research Center - Bellevue, Washington 2,481.0 miles None None None
Northwest Clinical Research Center - Bellevue, Washington 2,481.0 miles None None None
Northwest Clinical Research Center - Bellevue, Washington 2,481.0 miles None None None
Pacific Institute of Medical Sciences - Bothell, Washington 2,481.5 miles None None None
Pacific Institute of Medical Sciences - Bothell, Washington 2,481.5 miles None None None
Pacific Institute of Medical Sciences - Bothell, Washington 2,481.5 miles None None None
Seattle Childrens Research Institute Psychiatry and Behavioral Medicine - Seattle, Washington 2,490.2 miles None None None
Seattle Childrens Research Institute Psychiatry and Behavioral Medicine - Seattle, Washington 2,490.2 miles None None None
Seattle Childrens Research Institute Psychiatry and Behavioral Medicine - Seattle, Washington 2,490.2 miles None None None
PCSD Feighner Research - San Diego, California 2,580.0 miles None None None
PCSD Feighner Research - San Diego, California 2,580.0 miles None None None
PCSD Feighner Research - San Diego, California 2,580.0 miles None None None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.