Ot    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
193Prader-Willi syndrome18

193. Prader-Willi syndrome    [ 95 clinical trials,   104 drugs,   (DrugBank: 27 drugs),   50 drug target genes,   63 drug target pathways]
Searched query = "Prader-Willi syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
18 / 95 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04283578
(ClinicalTrials.gov)
March 10, 202019/2/2020Oxytocin Treatment in Neonates and Infants With Prader-Willi SyndromeOxytocin Treatment in Neonates and Infants Aged From 0 to 3 Months With Prader-Willi Syndrome : a Study of Safety and Efficacy on Oral and Social Skills and Feeding Behavior of Intranasal Administration of Oxytocin vs PlaceboPrader-Willi SyndromeDrug: OT;Drug: Placebo comparatorUniversity Hospital, ToulouseInternational Clinical Trials Association;Epidemiological and Clinical Research Information NetworkRecruitingN/A92 DaysAll48Phase 3France
2NCT04066088
(ClinicalTrials.gov)
December 1, 201921/8/2019Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi SyndromeDose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi SyndromePrader-Willi SyndromeOther: Placebo;Drug: Guanfacine extended release (GXR)NYU Langone HealthWinthrop University HospitalWithdrawn6 Years35 YearsAll0Phase 4United States
3NCT03831425
(ClinicalTrials.gov)
November 1, 201922/1/2019Mitochondrial Complex I Dysfunction in PWSMitochondrial Complex I Dysfunction in Prader Willi Syndrome: A New Therapeutic TargetPrader-Willi SyndromeDietary Supplement: Coenzyme Q10;Other: PlaceboThe Hospital for Sick ChildrenFoundation for Prader-Willi ResearchNot yet recruiting13 Years18 YearsAll14Phase 3NULL
4EUCTR2018-004216-22-GB
(EUCTR)
25/09/201927/06/2019A study to determine the safety of the study drug Diazoxide Choline Controlled-Release Tablet after being given for a long time to patients with the genetic disorder Prader-Willi Syndrome.An Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients with Prader-Willi Syndrome Hyperphagia associated with Prader-Willi Syndrome (PWS)
MedDRA version: 20.0;Level: PT;Classification code 10020710;Term: Hyperphagia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: diazoxide choline
Product Code: DCCR
INN or Proposed INN: Diazoxide choline
Other descriptive name: DIAZOXIDE CHOLINE
Soleno Therapeutics UK Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;United Kingdom
5EUCTR2019-002385-12-FR
(EUCTR)
27/08/201912/06/2019OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEOXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3 Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]University Hospital of ToulouseNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
48Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-002164-41-ES
(EUCTR)
03/07/201721/06/2017Study with adult patients with Prader-Willi syndrome, which evaluate the effect of growth hormone therapy on muscle tone and its relation with muscle strength and body composition assessed with imaging procedures.Growth hormone therapy in adults with Prader-Willi syndrome: Effect on muscle tone assessed by functional magnetic resonance imaging (fMRI) and its relation to muscle strenght and body composition. Patients with Prader-Willi Syndrome (SPW) with Growth hormone deficit.
MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Genotonorm Miniquick 0,2 mg
INN or Proposed INN: RECOMBINANT HUMAN GROWTH HORMON
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Fundació Parc TaulíNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Spain
7EUCTR2016-003694-18-CZ
(EUCTR)
18/01/201704/10/2016Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndromeA double-blind, randomized, placebo-controlled, multiple-dose, multi-centre safety and efficacy study of co-administration of tesofensine/metoprolol in subjects with Prader-Willi syndrome (PWS) Second 12 weeks open label extension Prader Willi syndrome (PWS)
MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tesofensine
INN or Proposed INN: Tesofensine
Other descriptive name: TESOFENSINE
Trade Name: Metoprololsuccinat ”Orion” 25mg
INN or Proposed INN: metoprolol
Other descriptive name: METOPROLOL SUCCINATE
Saniona A/SNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Hungary;Czech Republic
8NCT03081832
(ClinicalTrials.gov)
January 201710/3/2017Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants.Long Term Evaluation of Infants Aged From 3 to 4 Years Old Included in the Ancient Study (Repeated Administrations of Oxytocin in Infants With Prader Willi Syndrome Aged From 0 to 6 Months) and Comparison With Not Treated and Age-matched Prader Willi Syndrome Infants (OT2SUITE)Prader-Willi SyndromeDrug: Oxytocin;Other: ControlUniversity Hospital, ToulouseNULLCompleted3 Years4 YearsAll34N/AFrance
9EUCTR2015-000660-33-BE
(EUCTR)
21/03/201617/08/2015A clinical trial to study the efficacy and safety of an investigational medication, beloranib, in treatment of food-related behaviour and weight in obese individuals with Prader-Willi Syndrome by comparison with placeboRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks - bestPWS|EU Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Subcutaneous Beloranib in Suspension
Product Code: ZGN-440
INN or Proposed INN: Beloranib
Other descriptive name: Beloranib
Zafgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;Spain;Belgium;Denmark;Germany;Italy;United Kingdom;Sweden
10EUCTR2015-000660-33-SE
(EUCTR)
30/09/201511/08/2015A clinical trial to study the efficacy and safety of an investigational medication, beloranib, in treatment of food-related behaviour and weight in obese individuals with Prader-Willi Syndrome by comparison with placeboRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks - bestPWS II Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Subcutaneous Beloranib in Suspension
Product Code: ZGN-440
INN or Proposed INN: Beloranib
Other descriptive name: Beloranib
Zafgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;United States;Canada;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-000660-33-ES
(EUCTR)
12/08/201513/08/2015A clinical trial to study the efficacy and safety of an investigational medication, beloranib, in treatment of food-related behaviour and weight in obese individuals with Prader-Willi Syndrome by comparison with placeboRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks - bestPWS|EU Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Subcutaneous Beloranib in Suspension
Product Code: ZGN-440
INN or Proposed INN: Beloranib
Other descriptive name: Beloranib
Zafgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
12NCT02013258
(ClinicalTrials.gov)
March 201511/12/2013Oxytocin Trial in Prader-Willi SyndromeOxytocin Trial in Prader-Willi SyndromePrader Willi SyndromeDrug: Intranasal oxytocin;Other: PlaceboUniversity of FloridaNational Institutes of Health (NIH)Completed5 Years11 YearsAll24Phase 1United States
13NCT02368379
(ClinicalTrials.gov)
March 20145/2/2015Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi SyndromeDiagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi SyndromePrader Willi Syndrome;Adrenal InsufficiencyOther: Low dose (1 mcg) ACTH stimulation test;Other: Overnight metyrapone testNationwide Children's HospitalNULLCompleted2 YearsN/AAll23N/AUnited States
14EUCTR2011-001313-14-NL
(EUCTR)
17/10/201212/01/2012Young adult Prader-Willi StudyEffects of Growth Hormone after final height:A clinical care study to the optimal dosage of growth hormone in young adults with PWS.Young adult Prader-Willi StudyEffects of Growth Hormone after final height:A clinical care study to the optimal dosage of growth hormone in young adults with PWS. - Young Adult Prader Willi study Prader Willi Syndrome
MedDRA version: 14.1;Level: LLT;Classification code 10041331;Term: Somatotrophin;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: GENOTROPIN (Somatropin) is a growth hormone treatment. It is an exact copy of the natural growth hormone that our bodies make. The main difference is that GENOTROPIN is man-made.
Product Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: growth hormone
Dutch growth research foundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
15NCT01548521
(ClinicalTrials.gov)
July 201130/12/2011Tolerance of Intranasal Administration of OT in Prader-Willi Newborn BabiesTolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies and Effect on Suck and Food Intake.Prader-Willi SyndromeDrug: OxytocinUniversity Hospital, ToulouseNULLCompletedN/A5 MonthsAll5Phase 1;Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2019-002385-12-NL
(EUCTR)
08/09/2020Oxytocin treatment in neonates and infants aged from 0 to 3 months with prader-willi syndromeOxytocin treatment in neonates and infants aged from 0 to 3 months with prader-willi syndrome: a study of the safety and efficacy on oral and social skills and, feeding behavior of intranasal administrations of oxytocin vs. placebo (phase iii clinical trial) - OTBB3 Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Oxytocin
INN or Proposed INN: OXYTOCIN
Other descriptive name: OXYTOCIN
University Hospital of ToulouseNULLNAFemale: yes
Male: yes
48Phase 3France;Belgium;Netherlands
17EUCTR2010-022370-14-FR
(EUCTR)
15/11/2010Evaluation de la tolérance d'une administration intra-nasale d'ocytocine chez des nourrissons présentant un syndrome de Prader-Willi et de son effet sur la succion et la prise alimentaire. - OTBBEvaluation de la tolérance d'une administration intra-nasale d'ocytocine chez des nourrissons présentant un syndrome de Prader-Willi et de son effet sur la succion et la prise alimentaire. - OTBB Syndrome de Prader Willi
MedDRA version: 12.1;Level: LLT;Classification code 10036476;Term: Prader-Willi syndrome
Trade Name: SyntocinonCentre Hospitalier de ToulouseNULLNAFemale: yes
Male: yes
Phase 2France
18EUCTR2019-002385-12-BE
(EUCTR)
06/03/2020OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEOXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3 Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Oxytocin
INN or Proposed INN: OXYTOCIN
Other descriptive name: OXYTOCIN
University Hospital of ToulouseNULLNAFemale: yes
Male: yes
48Phase 3France;Belgium