Clinical trials: Disabilities, Intellectual
Fragile X Syndrome
Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome
There will be four study periods: Screening (up to 14 days in length), the Treatment Period (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days).
- Trial name
- Harbor-C (NCT01325220)
- Testing
- arbaclofen
- Where
- 28 sites in United States
- Volunteers
- 172 people
- Sponsor
- Seaside Therapeutics, Inc.
Prader-Willi Syndrome
Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.
- Trial name
- NCT03714373
- Testing
- DCCR
- Where
- 28 sites in United States, United Kingdom
- Volunteers
- 115 people
- Sponsor
- Soleno Therapeutics, Inc.
Prader-Willi Syndrome, Growth Hormone Deficiency
Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?
The purpose of this study is to estimate the sensibility at the growth hormone in vivo at the children presenting a Prader-Willi syndrome (SPW) in comparison with children presenting a deficit in growth hormone (GHD).
- Trial name
- NCT01298180
- Testing
- Growth hormone (Genotonorm® or Omnitrope®), DEXA, blood tests, H.G.P.O, osseous age., biopsy
- Where
- 26 sites in France
- Volunteers
- 111 people
- Sponsor
- University Hospital, Toulouse
Hyperekplexia, CTNNB1 Gene Mutation
Hyperekplexia in Patients With CTNNB1 Mutation
A few years ago, a new genetic disorder (OMIM # 615075) has been associated with loss-of-function variations in the CTNNB1 gene.
- Trial name
- CTNNB1 (NCT05168969)
- Testing
- Questionnaire
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Obesity
School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong
Considering that children with intellectual disability (ID) might be more vulnerable to obesity than their counterparts in the general population.
- Trial name
- NCT04463069
- Testing
- Adapted physical activity
- Where
- China
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Hong Kong Baptist University
Down Syndrome, Trisomy 21
Use of Partial Body Weight Support Play Environment to Encourage Mobility and Exploration in Infants With Down Syndrome
To explore the effects of Partial Body Weight Support (PBWS) within an enriched play environment for infants with Down Syndrome (DS), who are not yet walking, to better understand how PWBS may impact their mobility; exploration…
- Trial name
- NCT05307523
- Testing
- Enriched Play Environment with Partial Body Weight Support Harness, Enriched Play Environment without Partial Body Weight Support Harness
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Washington
Developmental Disability, Intellectual Disability
Fit Families Multisite
The purpose of the study is twofold. First, the investigator wants to identify the effect of a 12-week online fundamental motor skills (FMS) (e.g., throwing, catching, running) intervention on active participation in physical…
- Trial name
- NCT05451459
- Testing
- 12-week FMS Intervention, Physical Activities & Activity Booklets (via FitFamilies app)
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Down Syndrome, Vibration Therapy
Comparative Study of Two Applications on Muscle Strength, Balance and Motor Function in Children With Down Syndrome.
To differentiate between the efficacy of virtual reality and whole-body vibration on muscle strength, balance and motor function in children with down syndrome.
- Conditions
- Down Syndrome, Vibration Therapy, Virtual Reality
- Trial name
- NCT07816120
- Testing
- virtual reality, whole body vibration
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Cairo University
Depression
BEAT-IT: Behavioural Activation and Severe Learning Disabilities
Depression is common, but no psychological interventions have been tested to see if they work for adults with severe intellectual disabilities.
- Trial name
- NCT04744259
- Testing
- Behavioural Activation
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- NHS Greater Glasgow and Clyde
Motor Delay, Motor Skills Disorders
Motor Skill Proficiency After Equine-assisted Activities and Brain-building Tasks
There is no current research to support the efficacy of a combination of equine-assisted activities (EAA) and brain building activities to influence motor skill competencies in youth with neurodevelopmental disorders (ND).
- Conditions
- Motor Delay, Motor Skills Disorders, Autism Spectrum Disorder, Attention Deficit Hyper Activity
- Trial name
- NCT04158960
- Testing
- Equine-assisted activities, GaitWay program
- Volunteers
- 25 people
- Sponsor
- Texas Woman's University
Developmental Delay Disorders, Chromosome Deletion
Treatment Strategies for Children With Smith-Magenis Syndrome
This study will examine the effect of bright light or melatonin treatment on sleep in children with Smith-Magenis syndrome (SMS), a genetic disorder characterized by certain physical, behavioral and developmental features.
- Conditions
- Developmental Delay Disorders, Chromosome Deletion, Mental Retardation, Sleep Disorders, Circadian Rhythm
- Trial name
- NCT00506259
- Testing
- dTR Melatonin (NIH CC PDS), Phototherapy (Bright Light), Melatonin CR
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
Fragile X Syndrome
Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge
The aim of this study is to utilize neurophysiologic assessments, behavioral measures and clinical measures to assess how much deficits associated with Fragile X Syndrome from pre-dose to post-dose using pharmacology.
- Trial name
- NCT05418049
- Testing
- Baclofen, Memantine, Roflumilast
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Trisomy 21, Trisomy 18
Prenatal Screening for Down Syndrome With DNAFirst
This study will explore how maternal plasma circulating cell free DNA (ccfDNA) can be used as a primary screening test for Down syndrome as part of routine clinical care in the general pregnancy population.
- Conditions
- Trisomy 21, Trisomy 18, Trisomy 13, Monosomy X
- Trial name
- DNAFirst (NCT01966991)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Fragile X Syndrome, Autism Spectrum Disorders
Acamprosate in Youth With Fragile X Syndrome
Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS is inherited from the carrier parent, most often the mothers.
- Trial name
- NCT01300923
- Testing
- Acamprosate
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Indiana University
Aneuploidy, Trisomy 21
Non-Invasive Chromosomal Evaluation of Trisomy Study
This study is being conducted to provide clinically annotated samples to support continued improvements in the Ariosa Test content, methodology, specimen processing and quality control.
- Conditions
- Aneuploidy, Trisomy 21, Trisomy 18, Trisomy 13
- Trial name
- NICHE (NCT02201862)
- Where
- 3 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Cindy Cisneros
MPS II, Hunter Syndrome (MPS II)
An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta)
The objective of this study is to assess the long-term safety and efficacy of Hunterase for approximately 1 year in subjects who completed the end of study (EOS) visit (Visit 54) tests in the Phase 3 Hunterase study and patients…
- Conditions
- MPS II, Hunter Syndrome (MPS II), Hunter Syndrome, Hunterase
- Trial name
- NCT07344376
- Testing
- Hunterase
- Where
- South Korea
- Volunteers
- 30 people
- Sponsor
- GC Biopharma Corp
Down Syndrome
Non-drug Study to Assess the Suitability of Assessment Scales in Japanese Individuals With Down Syndrome Aged 6-30
To evaluate the suitability (i.e. number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values) of neurocognitive tests and functioning scales in…
- Trial name
- NCT02431117
- Where
- 7 sites in Japan
- Volunteers
- 43 people
- Sponsor
- Chugai Pharmaceutical
Fragile X Syndrome
Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001
The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 will be offered participation in 22001A which will evaluate secreted protein before and after treatment with STX209 and…
- Trial name
- NCT00823368
- Testing
- STX209
- Where
- 11 sites in United States
- Sponsor
- Seaside Therapeutics, Inc.
Creatine Deficiency, X-linked
Observational Study of Males With Creatine Transporter Deficiency
The objectives of this study are to illustrate the clinical, neuro/electrophysiologic, biochemical, and developmental status and progression of patients with Creatine Transporter Deficiency (CTD) and to evaluate the utility of…
- Trial name
- Vigilan (NCT02931682)
- Where
- 10 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Epilepsy, GLUT1DS1
Long-term Treatment With the Ketogenic Diet in Epilepsy
This study will provide a comprehensive assessment of long-term treatment with the ketogenic diet, a medical diet with high fat and low carbohydrate intake, focusing on safety and cardiovascular implications.
- Conditions
- Epilepsy, GLUT1DS1, PDH Deficiency
- Trial name
- NCT04646850
- Testing
- Color duplex ultrasound of the carotid arteries
- Where
- Norway
- Volunteers
- 30 people
- Sponsor
- Oslo University Hospital
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