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RG1662 in Individuals with Down Syndrome

  • Completed

The purpose of this study is to assess the safety and tolerability of the experimental drug RG1662 in individuals with Down syndrome.

Minimum Age Maximum Age Gender Healthy Volunteers
18 Years 30 Years Both No
November 2011
July 2013
33

++Males and nonpregnant, nonlactating females with a diagnosis of Down syndrome (confirmed by karyotype)++Parent or legal guardian/representative and caregiver willing to give written informed consent++Subject willing and consenting to participate

++Major depressive disorder not adequately controlled by a selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor++Clinical diagnosis of autistic spectrum disorder or attention deficit or hyperactivity disorder that makes study participation unlikely++Other primary psychiatric diagnosis++Evidence or clinical diagnosis of dementia++Personal history of cardiac abnormalities; patients that have previously undergone congenital heart surgery can be enrolled provided they have no residual complication requiring intervention (e.g., pacemaker)++Clinically significant obstructive pulmonary disease or asthma that is not adequately treated (oral steroids are not allowed)++Thyroid dysfunction that is not adequately controlled and stabilized on treatment for at least 8 weeks++Sustained elevated supine blood pressure exceeding 140/90 mmHg or notable resting tachycardia or blood pressure below 90/40 mmHg++Have taken any other investigational medications within past 3 months++Body mass index (BMI) of more than 40 kg/m2

The purpose of this study is to assess the safety and tolerability of RG1662 in individuals with Down syndrome. Eligible subjects will be randomized in cohorts to receive either multiple oral doses of RG1662 or a placebo. Anticipated time on study treatment is 38 days. RG1662 is an agonist of the GABA A receptor, a major inhibitory gateway in the brain.

For more information about this trial and its study sites, please call 1-888-662-6728 (U.S. only) or email genentechclinicaltrials@druginfo.com. Reference study ID number BP25543.

Name City State Zip Status Primary Contact
Site Phoenix Arizona 85013

Site Little Rock Arkansas 72204

Site La Jolla California 92037

Site Aurora Colorado 80045

Site Decatur Georgia 30033

Site Chicago Illinois 60612

Site Baltimore Maryland 21287

Site Durham North Carolina 27710

Hoffmann-La Roche

Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche

Name Phone Extension Email
Genentech Clinical Trials Information 888-662-6728 (U.S. only) genentechclinicaltrials@druginfo.com

A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Investigate Safety and Tolerability of RG1662 in Individuals With Down Syndrome