Down SyndromeNCT01920633
A Screening Protocol to Assess Adults and Adolescents With Down Syndrome for Eligibility For Upcoming Study of RG1662 (Study BP27832)
An observational study of Down Syndrome, run by Hoffmann-La Roche at 22 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Down Syndrome
- How many people
- 135 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 31 Oct 2013to 31 Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: People with Down syndrome
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United States9 sites
Johns Hopkins Hospital.
Baltimore, Maryland, 21287
Massachusette General Hospital; Medical Genetics
Boston, Massachusetts, 02114
Rush University Medical Center
Chicago, Illinois, 60612
UT Southwestern Medical Center
Dallas, Texas, 75390-8813
Emory University School of Medicine; Department of Human Genetics & Pediatrics
Decatur, Georgia, 30033
Duke Clin Rsch Institute
Durham, North Carolina, 27710
Univ of CA San Diego; Neurosciences Comp.Alzheimer's
La Jolla, California, 92037
University of Wisconsin Madison, Waisman Center
Madison, Wisconsin, 53705
University of Utah School of Medicine; Department of Pediatrics
Salt Lake City, Utah, 84112
Mexico3 sites
Clínica Para la Atención del Neurodesarrollo
Aguascalientes, 20030
Hospital Dr. Angel Leaño; Pediatria
Guadalajara, Jalisco, 45200
Hospital Médica Tec 100
Querétaro, 76000
New Zealand3 sites
Auckland Clinical Studies
Auckland, 1142
University of Otago; Psychological Medicine Department
Dunedin, 9016
Wellington Hospital Research Office
Wellington, 6021
Spain3 sites
IMIM, Human Pharmacology and Clinical Neurosciences,
Barcelona, 08009
Hospital Universitario de la Princesa; Medicina Interna
Madrid, 28006
UVaMID Hospital Santa Caterina;; Servicio de Neurología
Salt, Girona, 17090
Argentina2 sites
Instituto de Investigaciones Neurologicas Raul Carrea FLENI
Capital Federal, C1428AQK
Instituto Neurologia Bs As
Ciudad Autonoma de Bs As, 1426
Canada1 site
True North Clinical Research Kentville
Kentville, Nova Scotia, B4N 4K9
Singapore1 site
KK Women's and Children's Hospital; Department of Neonatology
Singapore, 229899
About this study
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)
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.
- Conditions
- Down Syndrome
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with Down syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of people with Down syndrome aged 12-30 eligible for upcoming BP27832 study of RG1662
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study start31 Oct 2013
- Primary completion31 Jan 2015
- Study completion31 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920633
- Sponsor's protocol ID
- BP28947
- Other IDs
- 2013-001264-33
- Status last verified
- Jul 2017
- First submitted
- 8 Aug 2013
- Last updated
- 19 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01920633
- Acronym / sponsor ID
- BP28947
- Conditions
- Down Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2013 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 31 Jan 2015 (actual)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with Down syndrome | – | – |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- People with Down syndrome
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of people with Down syndrome aged 12-30 eligible for upcoming BP27832 study of RG1662
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by Hoffmann-La Roche at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Mexico, New Zealand, Spain, Argentina and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of people with Down syndrome aged 12-30 eligible for upcoming BP27832 study of RG1662 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.