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

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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

Tracking Information
First Submitted Date  ICMJE December 27, 2013
First Posted Date  ICMJE December 31, 2013
Last Update Posted Date October 25, 2017
Actual Study Start Date  ICMJE May 5, 2014
Actual Primary Completion Date May 4, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2013)
  • Cognition as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) sub-tests [ Time Frame: 26 weeks ]
  • Adaptive behavior as assessed by the Vineland Adaptive Behavior Scales-II (VABS-II) standard scores [ Time Frame: 26 weeks ]
  • Clinical global impression as assessed by Clinician Rated Global Improvement (CGI-I) scale [ Time Frame: 26 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02024789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2014)
  • Incidence of abnormal ECG changes [ Time Frame: 26 weeks ]
  • Abnormal ECG changes in adolescents as compared to baseline [ Time Frame: from baseline to Week 26 ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 32 weeks ]
  • Incidence of abnormal blood pressure [ Time Frame: 26 weeks ]
  • RG1662 plasma concentrations [ Time Frame: 26 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2013)
  • Safety: Incidence of adverse events [ Time Frame: approximately 32 weeks ]
  • Incidence of abnormal ECG changes [ Time Frame: 26 weeks ]
  • Abnormal ECG changes in adolescents as compared to baseline [ Time Frame: from baseline to Week 26 ]
  • Incidence of abnormal blood pressure [ Time Frame: 26 weeks ]
  • RG1662 plasma concentrations [ Time Frame: 26 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Down Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: RG1662 120 mg bid
    Intervention: Drug: RG1662
  • Experimental: RG1662 240 mg bid
    Intervention: Drug: RG1662
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2016)
173
Original Estimated Enrollment  ICMJE
 (submitted: December 27, 2013)
180
Actual Study Completion Date  ICMJE May 4, 2016
Actual Primary Completion Date May 4, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   France,   Italy,   Mexico,   New Zealand,   Singapore,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02024789
Other Study ID Numbers  ICMJE BP27832
2013-001263-23 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date October 2017

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