A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS)
NCT ID: NCT02024789
Last Updated: 2017-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
173 participants
INTERVENTIONAL
2014-05-05
2016-05-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo
Orally twice daily, 26 weeks
RG1662 120 mg bid
RG1662
120 mg (80 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks
RG1662 240 mg bid
RG1662
240 mg (160 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Orally twice daily, 26 weeks
RG1662
120 mg (80 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks
RG1662
240 mg (160 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
12 Years
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univ of CA San Diego; Neurosciences Comp.Alzheimer's
La Jolla, California, United States
University of California DAVIS Medical Center; M.I.N.D. Institute, Section of Developmental Behavior
Sacramento, California, United States
Emory University School of Medicine; Department of Human Genetics & Pediatrics
Decatur, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Johns Hopkins Hospital.
Baltimore, Maryland, United States
Massachusette General Hospital; Medical Genetics
Boston, Massachusetts, United States
Duke Clin Rsch Institute
Durham, North Carolina, United States
University of Utah School of Medicine; Department of Pediatrics
Salt Lake City, Utah, United States
University of Wisconsin Madison, Waisman Center
Madison, Wisconsin, United States
FLENI
CABA, , Argentina
Instituto Neurologia Bs As
Ciudad Autonoma de Bs As, , Argentina
True North Clinical Research Kentville
Kentville, Nova Scotia, Canada
Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon
Bron, , France
CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique
Montpellier, , France
Institut Jérôme Lejeune; Neuropsychology
Paris, , France
CHU de Saint Etienne; Service de Génétique
Saint-Etienne, , France
Ospedale Pediatrico Bambino Gesù
Rome, Lazio, Italy
Policlinico Universitario "Agostino Gemelli";Dip. Tutela Salute Donna Bambino Adolescente
Rome, Lazio, Italy
Ospedale Microcitemico; Clinica Pediatrica
Cagliari, Sardinia, Italy
Hospital Dr. Angel Leaño; Pediatria
Guadalajara, Jalisco, Mexico
Clínica Para la Atención del Neurodesarrollo
Aguascalientes, , Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria
Monterrey, , Mexico
Hospital Médica Tec 100
Querétaro, , Mexico
Auckland Clinical Studies
Auckland, , New Zealand
University of Otago; Psychological Medicine Department
Dunedin, , New Zealand
Wellington Hospital Research Office
Wellington, , New Zealand
KK Women's and Children's Hospital; Department of Neonatology
Singapore, , Singapore
UVaMID Hospital Santa Caterina;; Servicio de Neurología
Salt, Girona, Spain
Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría
Santiago de Compostela, La Coruña, Spain
IMIM, Human Pharmacology and Clinical Neurosciences,
Barcelona, , Spain
Hospital Universitario de la Princesa; Medicina Interna
Madrid, , Spain
Hospital Infantil Universitario Niño Jesus; Pediatria Social
Madrid, , Spain
Fundación Síndrome de Down; Fundación Síndrome de Down
Madrid, , Spain
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
Doncaster and Bassetlaw Hospitals NHS Foundation Trust; Doncaster Royal Infirmary
Doncaster, , United Kingdom
Cornwall Partnership NHS Foundation Trust
Redruth, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Goeldner C, Kishnani PS, Skotko BG, Casero JL, Hipp JF, Derks M, Hernandez MC, Khwaja O, Lennon-Chrimes S, Noeldeke J, Pellicer S, Squassante L, Visootsak J, Wandel C, Fontoura P, d'Ardhuy XL; Clematis Study Group. A randomized, double-blind, placebo-controlled phase II trial to explore the effects of a GABAA-alpha5 NAM (basmisanil) on intellectual disability associated with Down syndrome. J Neurodev Disord. 2022 Feb 5;14(1):10. doi: 10.1186/s11689-022-09418-0.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-001263-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BP27832
Identifier Type: -
Identifier Source: org_study_id