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A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS)

NCT02024789 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2017-10-25

No results posted yet for this study

Summary

This multi-center, randomized, double-blind, 3-arm, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RG1662 in adults and adolescents with Down syndrome. Subjects will be randomized to receive RG1662 either at low or high dose or placebo orally twice daily for 26 weeks.

Conditions

  • Down Syndrome

Interventions

DRUG

Placebo

Orally twice daily, 26 weeks

DRUG

RG1662

120 mg (80 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks

DRUG

RG1662

240 mg (160 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-05
Primary Completion
2016-05-04
Completion
2016-05-04

Countries

  • United States
  • Argentina
  • Canada
  • France
  • Italy
  • Mexico
  • New Zealand
  • Singapore
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02024789 on ClinicalTrials.gov