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

Down Syndrome Clinical Trial

Official title:

A Screening Protocol to Assess Adult and Adolescent Individuals With Down Syndrome for Eligibility to Participate in an Upcoming Study to Evaluate the Efficacy, Safety and Tolerability of RG1662 (Study BP27832)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920633
• Other study ID #: BP28947
• Secondary ID: 2013-001264-33
• Status: Completed
• Phase: N/A
• First received: August 8, 2013
• Last updated: July 17, 2017
• Start date: October 31, 2013
• Est. completion date: January 31, 2015

Study information

• Verified date: July 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 31, 2015
• Est. primary completion date: January 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Locations

Country	Name	City	State
Argentina	Instituto de Investigaciones Neurologicas Raul Carrea FLENI	Capital Federal
Argentina	Instituto Neurologia Bs As	Ciudad Autonoma de Bs As
Canada	True North Clinical Research Kentville	Kentville	Nova Scotia
Mexico	Clínica Para la Atención del Neurodesarrollo	Aguascalientes
Mexico	Hospital Dr. Angel Leaño; Pediatria	Guadalajara	Jalisco
Mexico	Hospital Médica Tec 100	Queretaro
New Zealand	Auckland Clinical Studies	Auckland
New Zealand	University of Otago; Psychological Medicine Department	Dunedin
New Zealand	Wellington Hospital Research Office	Wellington
Singapore	KK Women's and Children's Hospital; Department of Neonatology	Singapore
Spain	IMIM, Human Pharmacology and Clinical Neurosciences,	Barcelona
Spain	Hospital Universitario de la Princesa; Medicina Interna	Madrid
Spain	UVaMID Hospital Santa Caterina;; Servicio de Neurología	Salt	Girona
United States	Johns Hopkins Hospital.	Baltimore	Maryland
United States	Massachusette General Hospital; Medical Genetics	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Emory University School of Medicine; Department of Human Genetics & Pediatrics	Decatur	Georgia
United States	Duke Clin Rsch Institute	Durham	North Carolina
United States	Univ of CA San Diego; Neurosciences Comp.Alzheimer's	La Jolla	California
United States	University of Wisconsin Madison, Waisman Center	Madison	Wisconsin
United States	University of Utah School of Medicine; Department of Pediatrics	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Mexico,  New Zealand,  Singapore,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of people with Down syndrome aged 12-30 eligible for upcoming BP27832 study of RG1662		1 day