| 1 |
NCT03440814 |
Not yet recruiting |
A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome |
|
- Drug: DCCR
- Drug: Placebo for DCCR
|
Interventional |
Phase 3 |
- Soleno Therapeutics, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Hyperphagia Score
- Body fat mass (DXA)
- CGI-I
- Caregiver GI-C
|
105 |
All |
8 Years and older (Child, Adult, Senior) |
NCT03440814 |
C601 |
|
March 2018 |
November 2018 |
December 2018 |
February 21, 2018 |
February 21, 2018 |
|
|
| 2 |
NCT02013258 |
Completed |
Oxytocin Trial in Prader-Willi Syndrome |
|
- Drug: Intranasal oxytocin
- Other: Placebo
|
Interventional |
Phase 1 |
- University of Florida
- National Institutes of Health (NIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Safety of intranasal oxytocin in children with Prader-Willi syndrome
- Evaluation of food intake in Prader-Willi syndrome
|
24 |
All |
5 Years to 11 Years (Child) |
NCT02013258 |
5208-N |
|
March 2015 |
August 2015 |
August 2015 |
December 17, 2013 |
April 5, 2018 |
|
- University of California, Irvine
Orange, California, United States - University of Florida
Gainesville, Florida, United States - University of Kansas Medical Center
Kansas City, Kansas, United States
|
| 3 |
NCT02034071 |
Completed |
Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome |
|
|
Interventional |
Phase 1
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Hyperphagia using hyperphagia questionnaire
- Resting energy expenditure
|
13 |
All |
10 Years to 22 Years (Child, Adult) |
NCT02034071 |
PC025 |
|
April 2014 |
May 2015 |
May 2015 |
January 13, 2014 |
September 1, 2016 |
|
- University of California, Irvine
Orange, California, United States
|
| 4 |
NCT03114371 |
Recruiting |
Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 Years |
|
- Drug: Oxytocin
- Drug: Placebo
|
Interventional |
Not Applicable |
- University Hospital, Toulouse
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Evolution of behavioural troubles evaluated by the global score of Child Behavior Check List Questionnaire after 12 weeks of oxytocin/placebo treatment.
- Evaluation of hyperphagia after 12 weeks of oxytocin/placebo treatment.
- Evaluation of social skills after 12 weeks of oxytocin/placebo treatment.
- (and 6 more...)
|
40 |
All |
3 Years to 12 Years (Child) |
NCT03114371 |
15 7837 03
2016-003273-18 |
Oxyjeune |
November 28, 2016 |
December 2019 |
December 2019 |
April 14, 2017 |
May 5, 2017 |
|
- Centre de référence du syndrome de Prader-Willi Hôpital des Enfants
Toulouse, France
|
| 5 |
NCT02311673 |
Completed |
Ph 2 Trial to Evaluate Safety & Efficacy of RM-493 in Obese Patients With Prader-Willi Syndrome |
|
- Drug: RM-493
- Drug: Placebo
|
Interventional |
Phase 2 |
- Rhythm Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Assess safety and tolerability of RM-493 (adverse events and clinical laboratory evaluations)
- Effect on weight loss
- Effect on hyperphagia-related behavior (using the PWS Hyperphagia Questionnaire)
- (and 5 more...)
|
40 |
All |
16 Years to 65 Years (Child, Adult) |
NCT02311673 |
RM-493-010
R01FD005094-01A1 |
|
February 2015 |
November 2016 |
December 2016 |
December 8, 2014 |
February 9, 2018 |
|
- University of California Irvine
Irvine, California, United States - University of Florida
Gainesville, Florida, United States - Kansas University Medical Center
Kansas City, Kansas, United States - (and 2 more...)
|
| 6 |
NCT03197662 |
Recruiting |
Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi Syndrome |
- Prader-Willi Syndrome
- Hyperphagia
|
- Drug: Intranasal Oxytocin (IN-OXT)
- Drug: Matched Placebo
|
Interventional |
Phase 2 |
- Montefiore Medical Center
- FDA Office of Orphan Products Development
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Hyperphagia Questionnaire for Clinical Trials
- Repetitive Behavior Scale Revised (RBS-R)
- BMI
- (and 5 more...)
|
50 |
All |
5 Years to 17 Years (Child) |
NCT03197662 |
2017-8076
FD-R-05106-01 |
|
April 2018 |
February 2020 |
August 2020 |
June 23, 2017 |
April 3, 2018 |
|
- Montefiore Medical Center, Albert Einstein College of Medicine
Bronx, New York, United States
|
| 7 |
NCT02205450 |
Unknown † |
Experience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of Sabadell |
|
- Drug: Recombinant Somatropin
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To assess the safe use of GH in children under 2 year old with Prader Willi Syndrome
- Evaluate the impact of treatment with GH in kids under 2 years old on body composition
- Evaluate the impact of treatment with GH in kids under 2 years old on start walking
- Evaluate the impact of treatment with GH in kids under 2 years old on the speech beginning
|
15 |
All |
up to 2 Years (Child) |
NCT02205450 |
CPT_ENDOPED201401 |
|
September 2014 |
September 2016 |
September 2016 |
July 31, 2014 |
July 31, 2014 |
|
- Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
|
| 8 |
NCT02629991 |
Active, not recruiting |
Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome |
- Prader-Willi Syndrome
- Hyperphagia
|
- Drug: Intranasal Oxytocin (IN-OXT)
- Drug: Matched Placebo
|
Interventional |
Phase 2 |
- Montefiore Medical Center
- Foundation for Prader-Willi Research
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Revised Dykens Hyperphagia Scale from Baseline to Endpoint.
- Change in Repetitive Behavior Scale (RBS-R) from Baseline to Endpoint.
- Change in Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS) from Baseline to Endpoint.
- (and 2 more...)
|
24 |
All |
5 Years to 18 Years (Child, Adult) |
NCT02629991 |
14-10-427-01 |
OXT-PWS |
October 2015 |
December 2016 |
May 2018 |
December 15, 2015 |
April 2, 2018 |
|
- Montefiore Medical Center, Albert Einstein College of Medicine
Bronx, New York, United States
|
| 9 |
NCT03245762 |
Completed |
Intranasal Oxytocin for Infants With Prader-Willi Syndrome |
|
- Drug: Oxytocin
- Drug: Placebo
|
Interventional |
Phase 1
Phase 2 |
- University of Florida
- Prader-Willi Syndrome Association
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Care Provider, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Suck and swallow competency in infants/children with PWS who are in nutritional phase 1a
- bonding between the parents and the infant.
|
15 |
All |
up to 6 Months (Child) |
NCT03245762 |
IRB201700423 -A |
|
August 1, 2017 |
January 4, 2018 |
January 4, 2018 |
August 10, 2017 |
April 10, 2018 |
|
- University of Florida
Gainesville, Florida, United States
|
| 10 |
NCT03274856 |
Recruiting |
A Study of GLWL-01 in Patients With Prader-Willi Syndrome |
|
- Drug: GLWL-01
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Post-treatment total score on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT)
- Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs
- Caregiver Global Impression of Change (CGIC)
- (and 2 more...)
|
34 |
All |
16 Years to 65 Years (Child, Adult) |
NCT03274856 |
GLWL-PWS |
|
February 20, 2018 |
September 14, 2018 |
September 14, 2018 |
September 7, 2017 |
April 5, 2018 |
|
- Rady Children's Hospital San Diego
San Diego, California, United States - University of Florida
Gainesville, Florida, United States - University Hospitals, Cleveland Medical Center
Cleveland, Ohio, United States - (and 4 more...)
|
| 11 |
NCT02829684 |
Recruiting |
Register of Patients With Prader-Willi Syndrome |
|
|
Observational |
|
- University Hospital, Toulouse
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- collect data about patients
|
500 |
All |
Child, Adult, Senior |
NCT02829684 |
07 315 03 |
|
March 2009 |
December 2020 |
December 2020 |
July 12, 2016 |
January 5, 2018 |
|
- University Hospital of Children
Toulouse, France
|
| 12 |
NCT02297022 |
Unknown † |
Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome |
|
- Device: Deep Brain Stimulation
|
Interventional |
Phase 1 |
- University of Sao Paulo General Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- waist circumference; mid−upper arm circumference
- resting energy expenditure
- Body mass index
- (and 5 more...)
|
6 |
All |
15 Years and older (Child, Adult, Senior) |
NCT02297022 |
InternalFunds |
DBSPW |
October 2014 |
October 2016 |
October 2016 |
November 21, 2014 |
December 16, 2015 |
|
- HCFUMSP
Sao Paulo, SP, Brazil
|
| 13 |
NCT03458416 |
Not yet recruiting |
A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Patients With Prader-Willi Syndrome |
|
- Drug: Cannabidiol Oral Solution
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Associated with Cannabidiol Oral Solution
- Number of Participants with Change from Baseline in Vital Signs
- Number of Participants with Change from Baseline in Physical Exam
- (and 3 more...)
|
66 |
All |
8 Years to 17 Years (Child) |
NCT03458416 |
INS011-17-115 |
|
June 2018 |
May 2020 |
May 2020 |
March 8, 2018 |
April 3, 2018 |
|
|
| 14 |
NCT03101826 |
Recruiting |
Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory |
|
- Behavioral: Listening Project Protocol
|
Interventional |
Not Applicable |
- Indiana University
- Latham Centers
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Effect of Intervention on Autonomic regulation
- Effect of Intervention on Heart period
- Effect of Intervention on Auditory processing
- (and 8 more...)
|
25 |
All |
13 Years to 25 Years (Child, Adult) |
NCT03101826 |
1609337519 |
|
November 1, 2017 |
May 2019 |
May 2019 |
April 5, 2017 |
November 17, 2017 |
|
- Latham Centers School
Brewster, Massachusetts, United States
|
| 15 |
NCT02804373 |
Recruiting |
Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome |
|
- Drug: Oxytocin continuous
- Drug: Placebo
- Drug: Placebo continuous
- Drug: Oxytocin
|
Interventional |
Phase 2
Phase 3 |
- University Hospital, Toulouse
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Behaviour as assessed by score variations in specific questionaries
- Change in eating Behaviour as assessed by score variations in specific questionaries
- Change in eating behaviour as assessed by score variations in hunger visual analogic scale
- (and 8 more...)
|
39 |
All |
18 Years to 50 Years (Adult) |
NCT02804373 |
13 6872 03 |
PRADOTIM |
June 2014 |
July 2016 |
July 2016 |
June 17, 2016 |
June 17, 2016 |
|
- Centre de référence Prader-Willi - Hôpital Purpan
Toulouse, France
|
| 16 |
NCT03081832 |
Recruiting |
Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants. |
|
- Drug: Oxytocin
- Other: Control
|
Interventional |
Not Applicable |
- University Hospital, Toulouse
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluation of communication skills.
- Evaluation of adaptative behavior composite and 3 domains : "Daily living skills", "Socialization", "Motor skills".
- Evaluation of behavioral troubles.
- (and 4 more...)
|
36 |
All |
3 Years to 4 Years (Child) |
NCT03081832 |
16/8407
2016-A01348-43 |
OT2SUITE |
January 2017 |
December 2018 |
December 2018 |
March 16, 2017 |
May 5, 2017 |
|
- Centre de référence du syndrome de Prader-Willi Hôpital des Enfants
Toulouse, France
|
| 17 |
NCT02844933 |
Not yet recruiting |
Cannabidiol Oral Solution for the Treatment of Subjects With Prader-Willi Syndrome |
|
- Drug: Cannabidiol
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from Baseline in the total score of the Hyperphagia Questionnaire for Clinical Trial (HQ-CT)
- Change from Baseline in Total Body-Weight
- Responder Rate from Baseline through Study Completion
- (and 4 more...)
|
66 |
All |
8 Years to 17 Years (Child) |
NCT02844933 |
INS011-16-085 |
|
April 2018 |
June 2019 |
June 2019 |
July 26, 2016 |
April 3, 2018 |
|
|
| 18 |
NCT02810483 |
Terminated |
Study of the Efficacy of Topiramate in Patients With Prader Willi Syndrome Over 8 Weeks |
|
- Drug: Topiramate
- Drug: Placebo Comparator
|
Interventional |
Phase 3 |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Clinical Global Impression Improvement
- Weight and size
- Self-Injury Behavior Scale ECAHA,
- (and 6 more...)
|
69 |
All |
12 Years to 45 Years (Child, Adult) |
NCT02810483 |
AOM10088 |
TOPRADER |
December 2012 |
November 2015 |
June 2016 |
June 23, 2016 |
April 11, 2018 |
|
- Hôpital La Pitié Salpêtrière
Paris, France
|
| 19 |
NCT00372125 |
Completed |
Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome |
|
- Drug: Norditropin SimpleXx
|
Interventional |
Not Applicable |
- Karolinska University Hospital
- Novo Nordisk A/S
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Changes in body composition (lean body mass and fat mass) measured by dual energy X-ray absorptiometry (DXA)
- Bone mineral density measured by DXA
- Effects on forced expiratory volume (Peakflow)
- (and 8 more...)
|
46 |
All |
18 Years to 50 Years (Adult) |
NCT00372125 |
CH1234 |
|
April 2005 |
March 2010 |
March 2010 |
September 6, 2006 |
September 13, 2016 |
|
- Center for rare Diseases, Department of Pediatrics, Skejby University Hospital
Aarhus N, Denmark - Endokrinologisk seksjon, Med Avd, Rikshospitalet
Oslo, Norway - Department of Endocrinology and Diabetology, Karolinska Hospital
Stockholm, Sweden
|
| 20 |
NCT02204163 |
Unknown † |
Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome |
|
- Drug: Eutropin
- Drug: Genotropin
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline in height SDS (Standard Deviation Score)
- Change from baseline in Lean body mass
- Change from baseline in Percent body fat
- (and 8 more...)
|
34 |
All |
Child, Adult, Senior |
NCT02204163 |
LG-HGCL007 |
|
June 2014 |
June 2017 |
July 2017 |
July 30, 2014 |
September 14, 2015 |
|
- Asan Medical Center
Seoul, Korea, Republic of - Samsung Medical Center
Seoul, Korea, Republic of
|
| 21 |
NCT01444898 |
Completed
Has Results |
Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome |
|
|
Interventional |
Not Applicable |
- Children's Hospital Los Angeles
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Weight
- % Change in Body Mass Index (BMI)
- Change in BMI Z-Score
- (and 6 more...)
|
10 |
All |
13 Years to 20 Years (Child, Adult) |
NCT01444898 |
CCI 11-00227 |
|
March 2012 |
May 2013 |
December 2013 |
October 3, 2011 |
September 29, 2016 |
September 29, 2016 |
- Children's Hospital of Los Angeles
Los Angeles, California, United States
|
| 22 |
NCT00932932 |
Completed |
Cortisol Activity in Patients With Prader-Willi Syndrome and Healthy Controls |
|
|
Observational |
|
- Children's Mercy Hospital Kansas City
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
|
36 |
All |
6 Months and older (Child, Adult, Senior) |
NCT00932932 |
09 01-014 |
|
February 2009 |
|
August 2010 |
July 7, 2009 |
June 27, 2011 |
|
|
| 23 |
NCT00399893 |
Terminated
Has Results |
Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS) |
|
- Drug: Octreotide
- Drug: Placebo
|
Interventional |
Not Applicable |
- Duke University
- National Institutes of Health (NIH)
- National Center for Research Resources (NCRR)
- Novartis
|
Other / NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Number of Participants With Decrease in Fasting Total Ghrelin
- Number of Participants With Decrease in Weight From Baseline to 6 Months
- Number of Participants With Decreased BMI Z-score From Baseline to 6 Months
- (and 8 more...)
|
5 |
All |
5 Years to 21 Years (Child, Adult) |
NCT00399893 |
Pro00005426
Protocol #00005426 |
|
December 2006 |
April 2009 |
September 2010 |
November 15, 2006 |
July 24, 2014 |
July 24, 2014 |
- Duke University Medical Center
Durham, North Carolina, United States
|
| 24 |
NCT00444964 |
Unknown † |
Growth Hormone Use in Adults With Prader-Willi Syndrome |
|
|
Interventional |
Phase 3 |
- Children's Mercy Hospital Kansas City
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Increased IGF-1 as a function of human growth hormone dosage compared with baseline
- Improvement of indicators or risk factors for co-morbid diseases [diabetes (by measuring insulin and glucose levels), cardiovascular disease (by measuring lipids and fatty acids), and pulmonary function] in participants.
- Improvement in quality of life measures as indicated by ratings on established behavior checklists in participants.
- (and 2 more...)
|
10 |
All |
16 Years to 60 Years (Child, Adult) |
NCT00444964 |
303-C02R |
|
April 2005 |
|
February 2007 |
March 8, 2007 |
March 8, 2007 |
|
- The Children's Mercy Hospital
Kansas City, Missouri, United States
|
| 25 |
NCT00551343 |
Unknown † |
Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome |
|
|
Interventional |
Not Applicable |
- Garvan Institute of Medical Research
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- satiety hormones
- appetite (visual analogue scale) insulin secretion
|
20 |
All |
18 Years to 45 Years (Adult) |
NCT00551343 |
H07/045
X07-0178 |
|
October 2007 |
|
September 2008 |
October 30, 2007 |
October 30, 2007 |
|
- Garvan Institute of Medical Research
Darlinghurst Sydney, New South Wales, Australia
|
| 26 |
NCT02179151 |
Terminated |
Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome |
- Prader-Willi Syndrome
- Obesity
|
- Drug: ZGN-440 for Injectable Suspension
- Drug: ZGN-440 Placebo for Injectable Suspension
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in total body weight
- Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire
- Change in LDL cholesterol
- (and 4 more...)
|
108 |
All |
12 Years to 65 Years (Child, Adult) |
NCT02179151 |
ZAF-311 |
bestPWS |
September 2014 |
December 2015 |
October 2016 |
July 1, 2014 |
January 26, 2017 |
|
- University of California, Davis
Sacramento, California, United States - UCSD: Rady Children's Hospital
San Diego, California, United States - Children's Hospital of Colorado
Aurora, Colorado, United States - (and 12 more...)
|
| 27 |
NCT00175305 |
Terminated |
Prader-Willi Syndrome and Appetite |
- Hyperphagia
- Prader-Willi Syndrome
|
|
Interventional |
Phase 3 |
- University of British Columbia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Changes in ghrelin concentrations during a test meal
- Change in weight, behaviour and food intake
|
10 |
All |
10 Years to 17 Years (Child) |
NCT00175305 |
C04-0007
W04-0007 |
|
August 2004 |
|
October 2007 |
September 15, 2005 |
October 31, 2007 |
|
- Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
|
| 28 |
NCT03149445 |
Recruiting |
Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS) |
- Confirmed Genetic Diagnosis of Prader-Willi Syndrome
|
- Drug: Tesofensine/Metoprolol
- Drug: Placebos
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline on body weight in subjects with PWS
|
15 |
All |
18 Years to 30 Years (Adult) |
NCT03149445 |
TM002 |
2016-003694-18 |
March 30, 2017 |
September 2018 |
October 2018 |
May 11, 2017 |
April 6, 2018 |
|
- Hospital Motol
Prague, Czechia
|
| 29 |
NCT01863017 |
Completed |
Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation-induced Modulation of Hyperphagia in Prader-Willi Syndrome |
- Hyperphagia
- Prader-Willi Syndrome
|
|
Interventional |
Not Applicable |
- University of Kansas Medical Center
- Prader-Willi Syndrome Association USA
- Harvard Medical School
- Foundation for Prader-Willi Research
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Amplitude of eyeblink startle responses
- Latency of eyeblink startle responses
|
52 |
All |
18 Years to 64 Years (Adult) |
NCT01863017 |
13155 |
|
April 2013 |
October 6, 2016 |
October 6, 2016 |
May 27, 2013 |
December 28, 2017 |
|
- University of Kansas Medical Center
Kansas City, Kansas, United States - Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States - Prader-Willi Homes of Oconomowoc
Dousman, Wisconsin, United States
|
| 30 |
NCT01897363 |
Completed |
Hypoglycemia in Prader-Willi Syndrome |
- Prader Willi Syndrome
- Hypoglycemia
|
- Other: Infants with Prader-Willi Syndrome
|
Observational |
|
- University of Florida
- Foundation for Prader-Willi Research
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
2 |
All |
2 Months to 12 Months (Child) |
NCT01897363 |
59-2013 |
|
July 2013 |
August 2014 |
September 2014 |
July 12, 2013 |
September 25, 2014 |
|
- University of Florida
Gainesville, Florida, United States
|
| 31 |
NCT00603109 |
Unknown † |
Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi Syndrome |
|
- Drug: rimonabant
- Drug: placebo
|
Interventional |
Phase 3 |
- Weill Medical College of Cornell University
- National Institutes of Health (NIH)
- PWSAUSA
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Body Weight and Body fat mass
- IGF-1, Leptin, Ghrelin, Serum Lipids and insulin sensitivity
|
18 |
All |
18 Years to 35 Years (Adult) |
NCT00603109 |
0611008841 |
PWS |
August 2007 |
June 2008 |
August 2008 |
January 28, 2008 |
January 4, 2011 |
|
- New York Presbyterian Hospital-Weill Cornell Medical College
New york, New York, United States
|
| 32 |
NCT01622751 |
Completed |
Plasma Adiponectin Level and Sleep Structures in Children With Prader-Willi Syndrome |
- Prader-Willi Syndrome
- Obesity
|
|
Observational |
|
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
|
46 |
All |
5 Years to 12 Years (Child) |
NCT01622751 |
2006-09-055 |
|
January 2007 |
|
June 2007 |
June 19, 2012 |
June 19, 2012 |
|
|
| 33 |
NCT01479322 |
Completed |
Plasma Adiponectin Level and Vascular Endothelial and Smooth Muscle Cell Function in Children With Prader-Willi Syndrome |
- Prader-Willi Syndrome
- Obesity
|
|
Observational |
|
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
|
51 |
All |
6 Years to 18 Years (Child, Adult) |
NCT01479322 |
2006-11-056 |
|
January 2007 |
|
July 2007 |
November 24, 2011 |
November 24, 2011 |
|
|
| 34 |
NCT00800852 |
Completed |
Increased Expression of Adiponectin Receptor 2 in the Mononuclear Cells in Children With Prader-Willi Syndrome |
- Obesity
- Prader-Willi Syndrome
|
|
Observational |
|
|
Other |
|
|
|
All |
up to 18 Years (Child, Adult) |
NCT00800852 |
2008-10-040 |
|
|
|
|
December 2, 2008 |
December 2, 2008 |
|
|
| 35 |
NCT01298180 |
Completed |
Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome? |
- Prader-Willi Syndrome
- Growth Hormone Deficiency
|
- Drug: Growth hormone (Genotonorm® or Omnitrope®)
- Procedure: DEXA, blood tests, H.G.P.O, osseous age.
- Procedure: biopsy
|
Interventional |
Phase 4 |
- University Hospital, Toulouse
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Measure of the circulating rates of IGF-I under treatment.
- Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin.
- Measure of physical composition's variation.
- (and 2 more...)
|
111 |
All |
1 Year to 5 Years (Child) |
NCT01298180 |
0811601
National PHRC 2008 |
|
January 2009 |
May 2013 |
May 2013 |
February 17, 2011 |
May 27, 2015 |
|
- CHU Amiens Hôpital Nord Service Pédiatrie - Place Victor Pauchet
Amiens, France - CHU Angers - 4 rue Larrey
Angers, France - CHG Avignon - 305, rue Raoul Follereau
Avignon, France - (and 23 more...)
|
| 36 |
NCT00065923 |
Completed |
Treatment of Self-Injurious Behavior in Individuals With Prader-Willi Syndrome |
- Prader-Willi Syndrome
- Self-Injurious Behavior
|
|
Interventional |
Not Applicable |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double
- Primary Purpose: Treatment
|
|
10 |
All |
18 Years to 66 Years (Adult, Senior) |
NCT00065923 |
R03HD042818 |
|
July 2002 |
December 2005 |
|
August 5, 2003 |
May 1, 2013 |
|
- University of Florida-Brain Institute
Gainesville, Florida, United States
|
| 37 |
NCT02058342 |
Unknown † |
Family-based Intervention for Youth With Prader-Willi Syndrome: The Active Play at Home Study |
- Prader Willi Syndrome
- Childhood Obesity
|
- Behavioral: Active Play at Home
|
Interventional |
Not Applicable |
- California State University, Fullerton
- University of Florida
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Physical Activity
- Body composition
- Motor proficiency
- (and 3 more...)
|
115 |
All |
8 Years to 15 Years (Child) |
NCT02058342 |
HSR-13-0142.54155
W81XWH-09-1-0682 |
APAH |
May 2011 |
June 2015 |
October 2015 |
February 10, 2014 |
February 10, 2014 |
|
- California State University Fullerton
Fullerton, California, United States - University of Florida Gainesville
Gainesville, Florida, United States
|
| 38 |
NCT02368379 |
Completed |
Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome |
- Prader Willi Syndrome
- Adrenal Insufficiency
|
- Other: Low dose (1 mcg) ACTH stimulation test
- Other: Overnight metyrapone test
|
Interventional |
Not Applicable |
- Nationwide Children's Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Presence of central adrenal insufficiency using low dose (1 mcg) ACTH stimulation test
- Prescence of central adrenal insufficiency using overnight metyrapone test
- Determine peak cortisol value on low dose (1 mcg) ACTH stimulation test that can accurately predict central adrenal insufficiency based on overnight metyrapone test with good sensitivity and specificity.
|
23 |
All |
2 Years and older (Child, Adult, Senior) |
NCT02368379 |
293113 |
|
March 2014 |
August 2016 |
August 2016 |
February 23, 2015 |
January 29, 2018 |
|
- Nationwide Children's Hospital
Columbus, Ohio, United States
|
| 39 |
NCT00808548 |
Unknown † |
Exploring Stress and Coping Behaviors of the Major Carer Whose Children With Prader-Willi Syndrome |
|
- Other: counseling, emotional support
- Other: emotional support
|
Observational |
|
- Taichung Veterans General Hospital
|
Other |
- Observational Model: Case-Only
- Time Perspective: Retrospective
|
|
8 |
All |
6 Years to 12 Years (Child) |
NCT00808548 |
C08169 |
|
December 2008 |
February 2009 |
December 2009 |
December 16, 2008 |
December 16, 2008 |
|
- Taichung Veterans General Hospital
Taichung, Taiwan
|
| 40 |
NCT02529085 |
Recruiting |
PWS European Blood Bank for Infants and Controls From 0 to 48 Months |
|
|
Interventional |
Not Applicable |
- University Hospital, Toulouse
- European Society for Paediatric Endocrinology
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Levels of hormones and neuropeptides
- Correlation between hormones and neuropeptides levels
|
500 |
All |
up to 18 Years (Child, Adult) |
NCT02529085 |
12 359 03 |
|
March 2013 |
March 2017 |
December 2017 |
August 19, 2015 |
May 9, 2016 |
|
- Unité d'Endocrinologie Pédiatrique / Université Catholique de Louvain
Brussels, Belgium - Department of Pediatrics / Division of Endocrinology
Toulouse, Haute-Garonne, France - Department of Endocrinology / University Children's Hospital
Essen, Germany - (and 3 more...)
|
| 41 |
NCT01520467 |
Active, not recruiting |
Aromatase Inhibitor in Bone Maturation, Children With Silver Russell or Prader-Willi Syndrome |
- Silver Russell Syndrome
- Prader-Willi Syndrome
|
- Drug: Anastrozole
- Drug: Placebo
|
Interventional |
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The rate of success in each of the two groups, evaluated using an X-ray of the left hand and wrist. Success is defined as a difference in the rate of progression of bone maturation of at least 9 months after 18 months of treatment.
- metabolic impact (monitoring of body composition by bi photonic absorptiometry, lipid, glucose, HbA1c, insulin and HOMA-IR profiles, leptin).
- impact on bone (X-ray of the dorsolumbar spine, bi photonic absorptiometry, blood-borne markers of bone remodeling).
- (and 2 more...)
|
27 |
All |
5 Years to 12 Years (Child) |
NCT01520467 |
P 100129
AOM 10093 |
ANASILPRA |
April 2012 |
July 2016 |
October 2016 |
January 30, 2012 |
August 24, 2016 |
|
- Explorations Fonctionnelles d'Endocrinologie - Centre de Référence des Maladies Endocriniennes Rares de la Croissance Hôpital Armand Trousseau
Paris, France
|
| 42 |
NCT00705172 |
Completed |
Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi Syndrome |
- Genetic Disorder
- Prader-Willi Syndrome
|
|
Observational |
|
|
Industry |
- Time Perspective: Retrospective
|
- Primary objective is to investigate changes in height Standard Deviation Score (SDS)
- Changes in height SDS from start of treatment to last observation during Norditropin treatment (referenced to PWS population1)
- Change in body composition (DEXA, Bio impedance or stable isotope dilution)
- (and 6 more...)
|
41 |
All |
up to 15 Years (Child) |
NCT00705172 |
GHLIQUID-1961 |
|
November 2008 |
November 2008 |
November 2008 |
June 25, 2008 |
December 23, 2014 |
|
- Arhus N, Denmark
- Hildesheim, Germany
- Zürich, Switzerland
|
| 43 |
NCT00742664 |
Completed |
Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project |
- Prader Willi Syndrome
- Obsessive-compulsive Disorder
|
- Behavioral: Cognitive-behavioral therapy
- Behavioral: Wait-list control
|
Interventional |
Phase 1
Phase 2 |
- University of South Florida
- Johns Hopkins All Children's Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Scahill et al., 1997).
- Clinical Global Improvement (CGI; Guy, 1976).
|
24 |
All |
6 Years to 17 Years (Child) |
NCT00742664 |
FPWR-CBT-001 |
|
September 2008 |
July 2011 |
July 2011 |
August 28, 2008 |
August 8, 2011 |
|
- All Children's Hospital
St. Petersburg, Florida, United States
|
| 44 |
NCT01613495 |
Completed |
Ghrelin Suppression by Octreotide in Prader-Willi |
|
- Drug: Placebo
- Drug: Octreotide
|
Interventional |
Not Applicable |
- Oregon Health and Science University
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Ghrelin levels
- Appetite
- Body weight
- (and 4 more...)
|
2 |
Male |
18 Years and older (Adult, Senior) |
NCT01613495 |
eIRB #1265
OCTRI # __910_____ |
|
August 2005 |
March 2009 |
November 2010 |
June 7, 2012 |
June 7, 2012 |
|
|
| 45 |
NCT00375089 |
Completed |
Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity |
- Prader-Willi Syndrome
- Obesity
|
- Other: Group 1
- Other: Group 2
|
Observational |
|
- University of Florida
- Office of Rare Diseases (ORD)
- Rare Diseases Clinical Research Network
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Phenotypic assessments of participants
- longitudinal pattern of progression
|
392 |
All |
up to 60 Years (Child, Adult) |
NCT00375089 |
RDCRN 5202
U54HD061222
ARP 5202 |
|
September 2006 |
January 2014 |
January 2014 |
September 12, 2006 |
September 22, 2014 |
|
- University of California at Irvine
Orange, California, United States - University of Florida
Gainesville, Florida, United States - Kansas University Medical Center
Kansas City, Kansas, United States - Vanderbilt University Medical Center
Nashville, Tennessee, United States
|
| 46 |
NCT02011360 |
Completed |
Prader-Willi Syndrome Macronutrient Study |
- Prader Willi Syndrome
- Syndromic Obesity
- Childhood Obesity
|
- Other: Low Carbohydrate diet
- Other: Low Fat diet
|
Interventional |
Not Applicable |
- Duke University
- Foundation for Prader-Willi Research
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
- Suppression of ghrelin
- Changes in satiety
- Improvements in insulin sensitivity
|
10 |
All |
5 Years to 17 Years (Child) |
NCT02011360 |
Pro00049226
SFR2382 |
|
May 2014 |
May 2016 |
May 2016 |
December 13, 2013 |
December 14, 2016 |
|
- Duke University Medical Center
Durham, North Carolina, United States - University of Alberta
Edmonton, Alberta, Canada
|
| 47 |
NCT01968187 |
Completed |
Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome |
- Hyperphagia in Prader-Willi Syndrome
|
- Drug: FE 992097
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Change in total hyperphagia score as measured by a Hyperphagia for Prader-Willi Syndrome Questionnaire
- Clinical Global Impression - Improvement score
- Change in Hyperphagia for Prader-Willi Syndrome Questionnaire domain scores
- (and 2 more...)
|
38 |
All |
10 Years to 18 Years (Child, Adult) |
NCT01968187 |
000114 |
|
January 2014 |
July 2014 |
July 2014 |
October 23, 2013 |
July 28, 2015 |
|
- Florida University
Gainesville, Florida, United States - Winthrop University
Mineola, New York, United States - Vanderbilt University
Nashville, Tennessee, United States
|
| 48 |
NCT01523288 |
Completed |
The Intestinal Function in People With Prader-Willi Syndrome |
- Prader-Willi Syndrome
- Constipation
- Incontinence
|
|
Observational |
|
- Aarhus University Hospital
|
Other |
- Observational Model: Case Control
|
- Colonic Transit time
- Rectal diameter
|
21 |
All |
18 Years and older (Adult, Senior) |
NCT01523288 |
PWS-1051 |
|
February 2011 |
January 2012 |
January 2012 |
February 1, 2012 |
February 1, 2012 |
|
- Centre of Rare Diseases, Pediatric department, Aarhus University Hospital Skejby
Aarhus, Aarhus N, Denmark
|
| 49 |
NCT01542242 |
Terminated |
Liraglutide Use in Prader-Willi Syndrome |
- Diabetes Mellitus Type 2
- Prader Willi Syndrome
|
|
Interventional |
Phase 4 |
- Vancouver General Hospital
- Novo Nordisk A/S
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Hemoglobin A1C
- Fasting Blood Glucose (mmol/L)
- Fasting Blood Insulin level
- (and 4 more...)
|
1 |
Male |
19 Years and older (Adult, Senior) |
NCT01542242 |
PWS.VGH.UBC |
|
February 2012 |
March 2013 |
March 2013 |
March 2, 2012 |
December 9, 2015 |
|
- Vancouver General Hospital - Diamond Center
Vancouver, British Columbia, Canada
|
| 50 |
NCT01818921 |
Completed |
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome |
- Obesity
- Over-weight
- Prader-Willi Syndrome
|
- Drug: ZGN-440 sterile diluent
- Drug: 1.2 mg ZGN-440 for injectable suspension
- Drug: 1.8 mg ZGN-440 for injectable suspension
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent change in body weight from baseline to the end of the randomized dosing period.
- Change in body weight (kg) from baseline to the end of the randomized dosing period
- Change in hyperphagia behavior, drive, and severity score (total score) from baseline to the end of the randomized dosing period using the PWS Hyperphagia Questionnaire
|
17 |
All |
16 Years to 65 Years (Child, Adult) |
NCT01818921 |
ZAF-211 |
|
June 2013 |
November 2013 |
November 2013 |
March 27, 2013 |
July 18, 2016 |
|
- University of Florida
Gainesville, Florida, United States
|
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