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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01920633
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date August 8, 2013
First Posted Date August 12, 2013
Last Update Posted Date July 19, 2017
Actual Study Start Date October 31, 2013
Actual Primary Completion Date January 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 8, 2013)
Identification of people with Down syndrome aged 12-30 eligible for upcoming BP27832 study of RG1662 [ Time Frame: 1 day ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Screening Protocol to Assess Adults and Adolescents With Down Syndrome for Eligibility For Upcoming Study of RG1662 (Study BP27832)
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)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population People with Down syndrome
Condition Down Syndrome
Intervention Not Provided
Study Groups/Cohorts People with Down syndrome
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 11, 2015)
135
Original Estimated Enrollment
 (submitted: August 8, 2013)
170
Actual Study Completion Date January 31, 2015
Actual Primary Completion Date January 31, 2015   (Final data collection date for primary outcome measure)
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
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Canada,   Mexico,   New Zealand,   Singapore,   Spain,   United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number NCT01920633
Other Study ID Numbers BP28947
2013-001264-33 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor Hoffmann-La Roche
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2017