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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01920633




Registration number
NCT01920633
Ethics application status
Date submitted
8/08/2013
Date registered
12/08/2013
Date last updated
19/07/2017

Titles & IDs
Public title
A Screening Protocol to Assess Adults and Adolescents With Down Syndrome for Eligibility For Upcoming Study of RG1662 (Study BP27832)
Scientific 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)
Secondary ID [1] 0 0
2013-001264-33
Secondary ID [2] 0 0
BP28947
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Down Syndrome 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Down's syndrome
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
People with Down syndrome -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Identification of people with Down syndrome aged 12-30 eligible for upcoming BP27832 study of RG1662
Timepoint [1] 0 0
1 day

Eligibility
Key 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
Minimum age
12 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2015
Sample size
Target
Accrual to date
Final
135
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
United States of America
State/province [9] 0 0
Wisconsin
Country [10] 0 0
Argentina
State/province [10] 0 0
Capital Federal
Country [11] 0 0
Argentina
State/province [11] 0 0
Ciudad Autonoma de Bs As
Country [12] 0 0
Canada
State/province [12] 0 0
Nova Scotia
Country [13] 0 0
Mexico
State/province [13] 0 0
Jalisco
Country [14] 0 0
Mexico
State/province [14] 0 0
Aguascalientes
Country [15] 0 0
Mexico
State/province [15] 0 0
Queretaro
Country [16] 0 0
New Zealand
State/province [16] 0 0
Auckland
Country [17] 0 0
New Zealand
State/province [17] 0 0
Dunedin
Country [18] 0 0
New Zealand
State/province [18] 0 0
Wellington
Country [19] 0 0
Singapore
State/province [19] 0 0
Singapore
Country [20] 0 0
Spain
State/province [20] 0 0
Girona
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01920633
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01920633