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Trial record 69 of 321 for:    down syndrome

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

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

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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

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




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 ]


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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

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


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Locations
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United States, California
Univ of CA San Diego; Neurosciences Comp.Alzheimer's
La Jolla, California, United States, 92037
University of California DAVIS Medical Center; M.I.N.D. Institute, Section of Developmental Behavior
Sacramento, California, United States, 95817
United States, Georgia
Emory University School of Medicine; Department of Human Genetics & Pediatrics
Decatur, Georgia, United States, 30033
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Hospital.
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusette General Hospital; Medical Genetics
Boston, Massachusetts, United States, 02114
United States, North Carolina
Duke Clin Rsch Institute
Durham, North Carolina, United States, 27710
United States, Utah
University of Utah School of Medicine; Department of Pediatrics
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
University of Wisconsin Madison, Waisman Center
Madison, Wisconsin, United States, 53705
Argentina
FLENI
Caba, Argentina, C1428AQK
Instituto Neurologia Bs As
Ciudad Autonoma de Bs As, Argentina, 1426
Canada, Nova Scotia
True North Clinical Research Kentville
Kentville, Nova Scotia, Canada, B4N 4K9
France
Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon
Bron, France, 69003
CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique
Montpellier, France, 34295
Institut Jérôme Lejeune; Neuropsychology
Paris, France, 75015
CHU de Saint Etienne; Service de Génétique
St Etienne, France, 42055
Italy
Ospedale Pediatrico Bambino Gesù
Roma, Lazio, Italy, 00165
Policlinico Universitario "Agostino Gemelli";Dip. Tutela Salute Donna Bambino Adolescente
Roma, Lazio, Italy, 00168
Ospedale Microcitemico; Clinica Pediatrica
Cagliari, Sardegna, Italy, 09121
Mexico
Hospital Dr. Angel Leaño; Pediatria
Guadalajara, Jalisco, Mexico, 45200
Clínica Para la Atención del Neurodesarrollo
Aguascalientes, Mexico, 20030
Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria
Monterrey, Mexico, 64460
Hospital Médica Tec 100
Queretaro, Mexico, 76000
New Zealand
Auckland Clinical Studies
Auckland, New Zealand, 1142
University of Otago; Psychological Medicine Department
Dunedin, New Zealand, 9016
Wellington Hospital Research Office
Wellington, New Zealand, 6021
Singapore
KK Women's and Children's Hospital; Department of Neonatology
Singapore, Singapore, 229899
Spain
UVaMID Hospital Santa Caterina;; Servicio de Neurología
Salt, Girona, Spain, 17090
Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría
Santiago de Compostela, La Coruña, Spain, 15706
IMIM, Human Pharmacology and Clinical Neurosciences,
Barcelona, Spain, 08009
Hospital Universitario de la Princesa; Medicina Interna
Madrid, Spain, 28006
Hospital Infantil Universitario Niño Jesus; Pediatria Social
Madrid, Spain, 28009
Fundación Síndrome de Down; Fundación Síndrome de Down
Madrid, Spain, 28016
United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust; Child Development and Family Support Centre
Blackpool, United Kingdom
Mental Health of Learning Disability, Kent & Medway NHS and Social Care Partnership Trust
Dartford, Kent, United Kingdom, DA2 6PB
Doncaster and Bassetlaw Hospitals NHS Foundation Trust; Doncaster Royal Infirmary
Doncaster, United Kingdom, DN2 5LT
Cornwall Partnership NHS Foundation Trust
Redruth, United Kingdom, TR15 2SP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02024789     History of Changes
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