Back to results

A Study of RG1662 in Individuals With Down Syndrome

Primary Purpose

Down Syndrome

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Placebo

RG1662

About this trial

This is an interventional treatment trial for Down Syndrome

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Safety: Incidence of adverse events

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT01436955

First Posted

August 18, 2011

Last Updated

March 2, 2015

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01436955

Brief Title

A Study of RG1662 in Individuals With Down Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Down Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

multiple oral doses

Intervention Type

Drug

Intervention Name(s)

RG1662

Intervention Description

Cohorts receiving multiple oral doses

Primary Outcome Measure Information:

Title

Safety: Incidence of adverse events

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

5-6 weeks

Title

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

Time Frame

5-6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72204

Country

United States

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

City

London

ZIP/Postal Code

NW10 7EW

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of RG1662 in Individuals With Down Syndrome

We'll reach out to this number within 24 hrs