Clinical Trial Protocol Registry

Trial information

A Study of RG1662 in Individuals With Down Syndrome

Status:
Completed
Protocol number:
BP25543
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Product name:
RG1662
Official Scientific Title:
A multi-center, randomized, double-blind, placebo-controlled, multiple dose study to investigate safety and tolerability of RG1662 in individuals with Down Syndrome
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. Target sample size is 35.
Study phase:
I
Study type:
Interventional; Treatment; Randomized; Double Blind; Parallel; Safety study
Conditions:
  • Down Syndrome
Primary outcome:
  1. Safety: Incidence of adverse events Time frame: 16 weeks
Key secondary outcomes:
  1. Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests Time frame: 5-6 weeks
  2. Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC) Time frame: 5-6 weeks
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
Gender:
Males or Females
Age limits:
Min: 18 years Max: 30 years
Accepts healthy volunteers:
No
Anticipated start date:
November, 2011
Trial registration date:
21.07.2011
Date last updated:
27.08.2014
This trial was conducted at the following locations:
UNITED KINGDOM
  • London
UNITED STATES
  • Little Rock, AR
  • Phoenix, AZ
  • La Jolla, CA
  • Orange, CA
  • Aurora, CO
  • Decatur, GA
  • Chicago, IL
  • Baltimore, MD
  • Durham, NC

Link to trial result

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