Status:
COMPLETED
A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Autism Spectrum Disorder
Eligibility:
MALE
18-45 years
Phase:
PHASE2
Brief Summary
This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult participants with ASD. In Stage I of...
Eligibility Criteria
Inclusion
- Participants meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for ASD and Tenth Revision of the International Classification of Diseases and Related Health Problems (ICD-10) criteria for Autism diagnosis
- 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
- Alcohol and/or substance abuse/dependence during the last 12 months
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT01793441
Start Date
September 1 2013
End Date
September 1 2016
Last Update
February 3 2017
Active Locations (56)
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1
Southwest Autism Research & Resource Center
Phoenix, Arizona, United States, 85006
2
Phoenix, Arizona, United States, 85006
3
University of California Davis
Sacramento, California, United States, 95817
4
Sacramento, California, United States, 95817