NCT01436955

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2011

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

August 18, 2011

Last Update Submit

March 2, 2015

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (1)

  • Safety: Incidence of adverse events

    16 weeks

Secondary Outcomes (2)

  • Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests

    5-6 weeks

  • Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC)

    5-6 weeks

Study Arms (2)

A

EXPERIMENTAL
Drug: RG1662

B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

multiple oral doses

B
RG1662DRUG

Cohorts receiving multiple oral doses

A

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Phoenix, Arizona, 85013, United States

Location

Unknown Facility

Little Rock, Arkansas, 72204, United States

Location

Unknown Facility

La Jolla, California, 92037, United States

Location

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

Decatur, Georgia, 30033, United States

Location

Unknown Facility

Chicago, Illinois, 60612, United States

Location

Unknown Facility

Baltimore, Maryland, 21287, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2011

First Posted

September 20, 2011

Study Start

November 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 3, 2015

Record last verified: 2015-03

Locations

US(8)GB(1)