A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
NCT ID: NCT01793441
Last Updated: 2017-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
223 participants
INTERVENTIONAL
2013-09-30
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants will receive placebo matching to RG7314 in each stage (Stage I, II, III and IV) for 12 weeks.
Placebo
Placebo will be administered in different stages of the study for 12 weeks.
RG7314
Participants will receive RG7314 orally at a dose of 1.5 mg/day in Stage I, 4 mg/day in Stage II, 10 mg/day in Stage III and 1.5 mg/day or 10 mg/day in Stage IV for 12 weeks.
RG7314
RG7314 will be administered orally at a dose of 1.5 mg/day in Stage I, 4 mg/day in Stage II, 10 mg/day in Stage III and 1.5 mg/day or 10 mg/day in Stage IV for 12 weeks.
Interventions
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Placebo
Placebo will be administered in different stages of the study for 12 weeks.
RG7314
RG7314 will be administered orally at a dose of 1.5 mg/day in Stage I, 4 mg/day in Stage II, 10 mg/day in Stage III and 1.5 mg/day or 10 mg/day in Stage IV for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* SRS-2 (T-score) greater than or equal to (\>/=) 66
* CGI-S \>/=4 (moderately ill)
* Participants have an Intelligence Quotient (IQ) \>/=70 (Wechsler Abbreviated State of Intelligence)
* A body mass index (BMI) between 18 to 40 kilograms per square meter (kg/m\^2) inclusive
* Language, hearing and vision compatible with the study measurements as judged by the investigator
* Lives with (or has substantial periods of contact with) a caregiver who is willing and able to attend visits when required, oversee the participant's compliance with protocol-specified procedures and study medication dosing, and report on the participant's status via completion of study assessments. Any period of absence must be covered by another caregiver. Non-cohabitating caregiver(s) must spend sufficient time with the participant so that, in the opinion of the investigator, the caregiver(s) can reliably assess participant's mental status, activities and behavior.
Exclusion Criteria
* A significant risk for suicidal behavior, in the opinion of the investigator
* Systolic blood pressure greater than (\>) 140 or less than (\<) 90 millimeters of mercury (mm Hg), and diastolic blood pressure \>90 or less than (\<) 50 mm Hg
* Resting pulse rate \>90 or \<40 beats per minute
* Use of prohibited medications or herbal remedies within 2 weeks prior to randomization, or 5 half-lives (whichever is longer)
* Initiation of a new major change in psychological intervention within 4 weeks prior to randomization. Minor changes in ongoing treatment are not considered significant
* Participation in an investigational drug or device study within 60 days prior to randomization
18 Years
45 Years
MALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Southwest Autism Research & Resource Center
Phoenix, Arizona, United States
Phoenix, Arizona, United States
University of California Davis
Sacramento, California, United States
Sacramento, California, United States
PCSD Feighner Research
San Diego, California, United States
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Stanford, California, United States
DBA IMMUNOe Int'l Res Center
Centennial, Colorado, United States
Centennial, Colorado, United States
Yale University; Yale Child Study Center
New Haven, Connecticut, United States
New Haven, Connecticut, United States
Neurology offices of south florida
Delray Beach, Florida, United States
Delray Beach, Florida, United States
Research Centers of America, LLC
Oakland Park, Florida, United States
Oakland Park, Florida, United States
Compass Research
Orlando, Florida, United States
Orlando, Florida, United States
Emory University School of Medicine; Department of Human Genetics & Pediatrics
Decatur, Georgia, United States
Decatur, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Chicago, Illinois, United States
The Kennedy Krieger Institute
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Neuroscientific Insights
Rockville, Maryland, United States
Rockville, Maryland, United States
Massachusetts General Hospital
Lexington, Massachusetts, United States
Lexington, Massachusetts, United States
University of Minnesota; Clin. Neuro Research Unit
Minneapolis, Minnesota, United States
Minneapolis, Minnesota, United States
Mount Sinai School of Medicine; Seaver Autism Center
New York, New York, United States
New York, New York, United States
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, United States
Orangeburg, New York, United States
Montefiore Medical Center; Departments of Psychiatry & Biobehavioral Science
The Bronx, New York, United States
The Bronx, New York, United States
DUKE SCHOOL OF MEDICINE;Duke Center for Autism and Brain Development
Durham, North Carolina, United States
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
University Hospitals
Cleveland, Ohio, United States
Cleveland, Ohio, United States
UPMC Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Road Runner Research
San Antonio, Texas, United States
San Antonio, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Bellevue, Washington, United States
Pacific Institute of Medical Sciences
Bothell, Washington, United States
Bothell, Washington, United States
Seattle Children's Research Institute
Seattle, Washington, United States
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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2012-005597-55
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BP28420
Identifier Type: -
Identifier Source: org_study_id
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