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

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: NCT02024789
Recruitment Status : Completed
First Posted : December 31, 2013
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Down Syndrome Drug: Placebo Drug: RG1662 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF RG1662 IN ADULTS AND ADOLESCENTS WITH DOWN SYNDROME (CLEMATIS)
Actual Study Start Date : May 5, 2014
Actual Primary Completion Date : May 4, 2016
Actual Study Completion Date : May 4, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Orally twice daily, 26 weeks
Experimental: RG1662 120 mg bid Drug: RG1662
120 mg (80 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks
Experimental: RG1662 240 mg bid Drug: RG1662
240 mg (160 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Cognition as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) sub-tests [ Time Frame: 26 weeks ]
  2. Adaptive behavior as assessed by the Vineland Adaptive Behavior Scales-II (VABS-II) standard scores [ Time Frame: 26 weeks ]
  3. Clinical global impression as assessed by Clinician Rated Global Improvement (CGI-I) scale [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Incidence of abnormal ECG changes [ Time Frame: 26 weeks ]
  2. Abnormal ECG changes in adolescents as compared to baseline [ Time Frame: from baseline to Week 26 ]
  3. Safety: Incidence of adverse events [ Time Frame: approximately 32 weeks ]
  4. Incidence of abnormal blood pressure [ Time Frame: 26 weeks ]
  5. RG1662 plasma concentrations [ Time Frame: 26 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals aged 12-30 years of age inclusive
  • Clinical diagnosis of Down syndrome (trisomy 21) confirmed by chromosomal analysis (karyotyping)
  • Males, or non-pregnant, non-lactating females. For females of childbearing potential, strict contraceptive prevention is required.
  • Body-mass Index (BMI) 18-42 and 15-30 kg/m2 inclusive for adults and adolescents respectively
  • Ability to complete the Clinical Evaluation of Language Fundamentals (CELF)-preschool 2 word classes task
  • Subjects must have a parent, or other reliable caregiver who agrees to accompany the subject to all clinic visits, provide information about the subject as required by the protocol, and ensure compliance with the medication schedule
  • Study participants must have sufficient language, vision and hearing to participate in study evaluations, as judged clinically by investigator

Exclusion Criteria:

  • Subjects with a current DSM 5 diagnosis of any primary psychiatric diagnosis (including ASD or MDD)
  • Subjects with a history of infantile spasms, of West syndrome, Lennox-Gastaut syndrome, Early Infantile Epileptic Encephalopathy or any treatment-refractory epilepsy associated with cognitive or developmental regression, of severe head trauma or CNS infections (e.g. meningitis)
  • Subjects with a known or suspected clinical seizure event of any type within 24 months prior to screening
  • Clinically relevant ECG abnormalities at screening or baseline; QTcF above 450 ms; personal or family history (first degree relatives) of congenital long QT syndrome
  • Inadequate renal or hepatic function
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024789


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02024789    
Other Study ID Numbers: BP27832
2013-001263-23 ( EudraCT Number )
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn