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

Completed · Phase 2 · Has a placebo group

Conditions studied: Down Syndrome

In brief

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.

Key facts

Study ID

NCT02024789

Run by

Hoffmann-La Roche

People needed

173

Starts

2014-05-05

Expected to finish

2016-05-04

Last updated by the study team

2017-10-25

Who can join

Age: 12 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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