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)

Hoffmann-La Roche22 sites in 7 countries135 target enrollmentOctober 31, 2013

ConditionsDown Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Down Syndrome
Sponsor: Hoffmann-La Roche
Enrollment: 135
Locations: 22
Primary Endpoint: Identification of people with Down syndrome aged 12-30 eligible for upcoming BP27832 study of RG1662
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 31, 2013

End Date

January 31, 2015

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

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