A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)



Status:Completed
Conditions:Neurology, Psychiatric, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 45
Updated:2/4/2017
Start Date:September 2013
End Date:September 2016

Use our guide to learn which trials are right for you!

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)

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.


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
We found this trial at
56
sites
482
mi
from 43215
Bronx, NY
Click here to add this to my saved trials
707 North Broadway
Baltimore, Maryland 21205
443-923-9200
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
345
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
97
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
795
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
344
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
1998
mi
from 43215
Bellevue, WA
Click here to add this to my saved trials
Bellevue, Washington 98007
1998
mi
from 43215
Bellevue, WA
Click here to add this to my saved trials
2001
mi
from 43215
Bothell, WA
Click here to add this to my saved trials
Bothell, Washington 98011
2001
mi
from 43215
Bothell, WA
Click here to add this to my saved trials
484
mi
from 43215
Bronx, NY
Click here to add this to my saved trials
1158
mi
from 43215
Centennial, CO
Click here to add this to my saved trials
7286 South Yosemite Street
Centennial, Colorado 80112
1158
mi
from 43215
Centennial, CO
Click here to add this to my saved trials
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
277
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
Cleveland, Ohio 44106
129
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
430
mi
from 43215
Decatur, GA
Click here to add this to my saved trials
432
mi
from 43215
Decatur, GA
Click here to add this to my saved trials
934
mi
from 43215
Delray Beach, FL
Click here to add this to my saved trials
4600 Linton Boulevard
Delray Beach, Florida 33445
949
mi
from 43215
Delray Beach, FL
Click here to add this to my saved trials
354
mi
from 43215
Durham, NC
Click here to add this to my saved trials
2608 Erwin Road
Durham, North Carolina 27705
352
mi
from 43215
Durham, NC
Click here to add this to my saved trials
636
mi
from 43215
Lexington, MA
Click here to add this to my saved trials
Lexington, Massachusetts 02142
636
mi
from 43215
Lexington, MA
Click here to add this to my saved trials
624
mi
from 43215
Minneapolis, MN
Click here to add this to my saved trials
720 Southeast Washington Avenue
Minneapolis, Minnesota 55414
623
mi
from 43215
Minneapolis, MN
Click here to add this to my saved trials
331
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37212
335
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
537
mi
from 43215
New Haven, CT
Click here to add this to my saved trials
230 South Frontage Road
New Haven, Connecticut 06510
536
mi
from 43215
New Haven, CT
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
480
mi
from 43215
New York, NY
Click here to add this to my saved trials
967
mi
from 43215
Oakland Park, FL
Click here to add this to my saved trials
Oakland Park, Florida 33334
966
mi
from 43215
Oakland Park, FL
Click here to add this to my saved trials
482
mi
from 43215
Orangeburg, NY
Click here to add this to my saved trials
482
mi
from 43215
Orangeburg, NY
Click here to add this to my saved trials
792
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
1662
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
1660
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
165
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
320
mi
from 43215
Rockville, MD
Click here to add this to my saved trials
Rockville, Maryland 20852
318
mi
from 43215
Rockville, MD
Click here to add this to my saved trials
2039
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
2043
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78258
1128
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92108
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
2107
mi
from 43215
San Francisco, CA
Click here to add this to my saved trials
San Francisco, California 94143
2109
mi
from 43215
San Francisco, CA
Click here to add this to my saved trials
1960
mi
from 43215
Santa Ana, CA
Click here to add this to my saved trials
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
Seattle, Washington 98105
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
2100
mi
from 43215
Stanford, CA
Click here to add this to my saved trials