A Study of RG1662 in Individuals With Down Syndrome
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01436955
First received: August 18, 2011
Last updated: May 7, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This multi-center, randomized double-blind, placebo-controlled study will 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 placebo. Anticipated time on study treatment is 38 days.
| Condition | Intervention | Phase |
|---|---|---|
|
Down Syndrome |
Drug: RG1662 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Safety: Incidence of adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests [ Time Frame: 5-6 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC) [ Time Frame: 5-6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 33 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: RG1662
Cohorts receiving multiple oral doses
|
| Placebo Comparator: B |
Drug: Placebo
multiple oral doses
|
Eligibility| Ages Eligible for Study: | 18 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult individuals, 18 to 30 years of age, with diagnosis of Down Syndrome (confirmed by karyotype)
- Males and non-pregnant non-lactating females
- Parent or legal guardian/representative and caregiver willing to give written informed consent
- Subject willing and assenting or consenting to participate
Exclusion Criteria:
- Major depressive disorder not adequately controlled by a selective serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor
- Subjects meeting clinical diagnostic criteria for autistic spectrum disorder, attention deficit or hyperactivity disorder unlikely to cooperate and take part successfully in the study assessments
- Subjects with other primary psychiatric diagnosis
- Subjects with evidence or meeting clinical diagnosis of dementia
- Subjects with 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. pace maker)
- Subjects with clinically significant obstructive pulmonary disease or asthma that is not adequately treated (oral steroids are not allowed)
- Subjects with thyroid dysfunction that is not adequately controlled and stabilized on treatment for at least 8 weeks
- Subjects with sustained elevated supine blood pressure (SBP/DBP) at rest exceeding 140/90 mmHg or notable resting tachycardia (mean HR > 60 bpm) or blood pressure below 90/40 mmHg
- Subjects who have taken any other investigational medications within 3 months
- Body mass index (BMI) > 40 kg/m2
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436955
Contacts
| Contact: Please reference Study ID Number: BP25543 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, Arizona | |
| Recruiting | |
| Phoenix, Arizona, United States, 85013 | |
| United States, Arkansas | |
| Completed | |
| Little Rock, Arkansas, United States, 72204 | |
| United States, California | |
| Recruiting | |
| La Jolla, California, United States, 92037 | |
| Not yet recruiting | |
| Orange, California, United States, 92868 | |
| United States, Colorado | |
| Terminated | |
| Aurora, Colorado, United States, 80045 | |
| United States, Georgia | |
| Recruiting | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Completed | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| Active, not recruiting | |
| Baltimore, Maryland, United States, 21287 | |
| United States, North Carolina | |
| Recruiting | |
| Durham, North Carolina, United States, 27710 | |
| United Kingdom | |
| Recruiting | |
| London, United Kingdom, NW10 7EW | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01436955 History of Changes |
| Other Study ID Numbers: | BP25543 |
| Study First Received: | August 18, 2011 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Down Syndrome Mental Retardation Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 21, 2013