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A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
Recruiting
Trial ID: NCT01793441
Purpose
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 the study, participants will be randomized in 2:1 to receive daily oral
doses of 1.5 milligrams (mg) RG7314 or placebo for 12 weeks. After an independent safety
review, the study may proceed to Stage II. In Stage II of the study, additional participants
will be randomized in 2:1 to receive daily oral doses of 4 mg RG7314 or placebo for 12 weeks.
After an independent safety review, Stage III will be started wherein additional participants
will be randomized in 2:1 to receive daily oral doses of 10 mg RG7314 or placebo for 12
weeks. During Stage III, safety will be reviewed by independent safety review twice and if no
safety signal is observed, then additional participants will be randomized in 1:1:1 either to
receive 1.5 milligrams per day (mg/day) or 10 mg/day RG7314 orally or placebo for 12 weeks in
Stage IV.
Official Title
A Multi-Center, Randomized, Double-Blind, 12-Week, Parallel Group, Placebo-Controlled Proof of Concept Study to Investigate the Efficacy and Safety of RG7314 in Individuals With Autism Spectrum Disorders (ASD)
Stanford Investigator(s)
Antonio Hardan, M.D.
Professor of Psychiatry and Behavioral Sciences
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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
Intervention(s):
drug: RG7314
drug: Placebo
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305