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

Hoffmann-La Roche0 sites35 target enrollmentNovember 2011

ConditionsDown Syndrome

InterventionsRG1662 Placebo

DrugsPlacebo RG1662

Overview

Phase: Phase 1
Intervention: RG1662
Conditions: Down Syndrome
Sponsor: Hoffmann-La Roche
Enrollment: 35
Primary Endpoint: Safety: Incidence of adverse events
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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 cohorts to receive either multiple oral doses of RG1662 or placebo. Anticipated time on study treatment is 38 days.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

September 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

A

Intervention: RG1662

B

Intervention: Placebo

Outcomes

Primary Outcomes

Safety: Incidence of adverse events

Time Frame: 16 weeks

Secondary Outcomes

Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC)(5-6 weeks)
Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests(5-6 weeks)