A Screening Protocol to Assess Adults and Adolescents With Down Syndrome for Eligibility For Upcoming Study of RG1662 (Study BP27832)

Completed

Conditions studied: Down Syndrome

In brief

This is a single visit study in which people with Down syndrome aged 12-30 will attend the clinical center to undergo assessments to evaluate their eligibility for potential enrollment in the future BP27832 Phase II clinical study which will evaluate the efficacy, safety and tolerability of RG1662. Study participants may withdraw from this study at any time and for any reason.

Key facts

Study ID: NCT01920633
Run by: Hoffmann-La Roche
People needed: 135
Starts: 2013-10-31
Expected to finish: 2015-01-31
Last updated by the study team: 2017-07-19

Who can join

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

You may qualify if…

Study participants will be assessed on the following criteria that they will be required to meet in order to participate in the future Phase II study BP27832:
Males and females 12-30 years of age (18-30 in the US)
Clinical diagnosis of Down syndrome (trisomy 21) documented by chromosomal analysis (karyotyping)
Body-mass Index (BMI) 18-42 and 15-32 kg/m2 inclusive for adults and adolescents respectively
Ability to complete the Clinical Evaluation of Language Fundamentals (CELF)-preschool 2 word classes task (i.e., ≥ 7 for the adults or ≥ 4 for the adolescents in the expressive raw score).
Study participant willing and assenting or consenting to participate
Parent or guardian willing to give written informed consent
Study participants must have a parent, or other reliable caregiver who will agree to accompany the study participant to clinic visits during the treatment study, BP27832
The parent or caregiver must be a constant and reliable informant with sufficient contact with the study participant to have detailed knowledge of the study participant's adaptive functioning in order to be able to complete assessments accurately
Study participants must be verbal and able to be understood most of the time and must not use other forms of communication, signs, symbol boards or devices as their primary form of communication
Study participants must have sufficient vision and hearing to participate in study evaluations
Study participants on anti-epileptic treatment must be on stable doses for 4 weeks prior to enrollment in the treatment protocol

You may not qualify if…

In the future Phase II study, study participants must not meet any of the following criteria :
Study participants with severe lactose intolerance
Study participants with moderate or severe Obstructive Sleep Apnea (OSA) as defined by Apnea-Hypopnea Index (AHI) (>15 events per hour not well controlled by positive airway pressure therapy with stable settings) for 6 weeks prior to the screening visit
Study participants with history of malignancy if not considered likely to be cured
Personal history of infantile spasms, of epilepsy, of severe head trauma or Central Nervous System (CNS) infections (e.g. meningitis), with the exception of a single isolated febrile seizure
Study participants with history of epilepsy within the last 2 years.
Evidence of active, clinically significant, and unstable gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease
Study participants with a current Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of any primary psychiatric diagnosis (including autism spectrum disorder). Diagnoses that are secondary, such as intellectual disability, attention deficit hyperactivity disorder, depression and conduct disorder are allowed as long as they are considered stable and to not interfere with conduct of a future treatment study
Study participants with a history of suicide attempt or deliberate self-harm due to suicidal ideation will not be included. Suicidal ideation (even in the absence of suicide attempt or deliberate self-harm) during the 6 months prior to screening
Concomitant use of excluded approved or unapproved medications
Personal or family history of congenital long QT syndrome
History of hepatitis C or known Human Immunodeficiency Virus (HIV) infection
Pregnant or breast feeding

Where it is running

Univ of CA San Diego; Neurosciences Comp.Alzheimer's — La Jolla, 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
UT Southwestern Medical Center — Dallas, Texas, 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
Instituto de Investigaciones Neurologicas Raul Carrea FLENI — Capital Federal, Argentina
Instituto Neurologia Bs As — Ciudad Autonoma de Bs As, Argentina
True North Clinical Research Kentville — Kentville, Nova Scotia, Canada
Hospital Dr. Angel Leaño; Pediatria — Guadalajara, Jalisco, Mexico
Clínica Para la Atención del Neurodesarrollo — Aguascalientes, 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
IMIM, Human Pharmacology and Clinical Neurosciences, — Barcelona, Spain
Hospital Universitario de la Princesa; Medicina Interna — Madrid, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.