Status:
COMPLETED
A Study of RG1662 in Individuals With Down Syndrome
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Down Syndrome
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
Brief Summary
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 cohort...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01436955
Start Date
November 1 2011
End Date
September 1 2013
Last Update
March 3 2015
Active Locations (9)
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1
Phoenix, Arizona, United States, 85013
2
Little Rock, Arkansas, United States, 72204
3
La Jolla, California, United States, 92037
4
Aurora, Colorado, United States, 80045