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A Study of RG1662 in Individuals With Down Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01436955
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):

August 18, 2011
September 20, 2011
March 3, 2015
November 2011
September 2013   (Final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: 16 weeks ]
Same as current
Complete list of historical versions of study NCT01436955 on ClinicalTrials.gov Archive Site
  • Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests [ Time Frame: 5-6 weeks ]
  • Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC) [ Time Frame: 5-6 weeks ]
Same as current
Not Provided
Not Provided
 
A Study of RG1662 in Individuals With Down Syndrome
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Investigate Safety and Tolerability of RG1662 in Individuals With Down Syndrome
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Down Syndrome
  • Drug: Placebo
    multiple oral doses
  • Drug: RG1662
    Cohorts receiving multiple oral doses
  • Experimental: A
    Intervention: Drug: RG1662
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
September 2013
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 30 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
 
 
NCT01436955
BP25543
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP