A Study of RG1662 in Individuals With Down Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01436955
First received: August 18, 2011
Last updated: August 26, 2014
Last verified: August 2014

August 18, 2011
August 26, 2014
November 2011
September 2013   (final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
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 ] [ 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 ]
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. Eligib le 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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
18 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT01436955
BP25543
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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