RG1662 in Individuals with Down Syndrome
RG1662 in Individuals with Down Syndrome
Overall Status:
Recruiting
Brief Description:
The purpose of this study is to assess the safety and tolerability of the experimental drug RG1662 in individuals with Down syndrome.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
18 Years | 30 Years | Both | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Detailed Description:
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.
Central Contact Information:
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.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 33.5080943, -112.0863874 | Phoenix | Arizona | 85013 | Recruiting | Name: Phone: | |
Geolocation is 34.7179437, -92.3714901 | Little Rock | Arkansas | 72204 | Completed | Name: Phone: | |
Geolocation is 32.84722, -117.27333 | La Jolla | California | 92037 | Recruiting | Name: Phone: | |
Geolocation is 33.78659, -117.8750976 | Orange | California | 92868 | Not yet recruiting | Name: Phone: | |
Geolocation is 39.7503186, -104.8367063 | Aurora | Colorado | 80045 | Terminated | Name: Phone: | |
Geolocation is 33.8092255, -84.2805478 | Decatur | Georgia | 30033 | Recruiting | Name: Phone: | |
Geolocation is 41.8816606, -87.6926257 | Chicago | Illinois | 60612 | Active, not recruiting | Name: Phone: | |
Geolocation is 39.2962372, -76.5928888 | Baltimore | Maryland | 21287 | Active, not recruiting | Name: Phone: | |
Geolocation is 36.0038131, -78.9387241 | Durham | North Carolina | 27710 | Recruiting | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
Hoffmann-La Roche |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Clinical Trials | Study Director | Hoffmann-La Roche |
Study Contact:
| Name | Phone | |
|---|---|---|
Genentech Clinical Trials Information | 888-662-6728 (U.S. only) |
Locations
ClinicalTrials.gov ID
NCT01436955 (follow link to view full record on ct.gov in new window)
Official Title:
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Investigate Safety and Tolerability of RG1662 in Individuals With Down Syndrome
Study Start Date:
November 2011
Study End Date:
July 2013
Disease Stage:
Pre-clinical
Enrollment:
33
