DDrare: Database of Drug Development for Rare Diseases

193. プラダー・ウィリ症候群
［臨床試験数：95，薬物数：104（DrugBank：27），標的遺伝子数：50，標的パスウェイ数：63］

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.

Drug = 1.2 mg ZGN-440 for injectable suspension; 1.8 mg ZGN-440 for injectable suspension; ACOMPLIA 20 mg film-coated tablets; ACTH; AZP-531; Acetylcysteine; Acomplia; Air; Anastrozole; B. lactis B94; Beloranib; Byetta; CBDV; CBDV Compound; Cannabidiol; Cannabidiol Oral Solution; Carbetocin; Chloride; Choline; Coenzyme Q10; D.3.2 Product code where applicable13:; DCCR; DIAZOXIDE CHOLINE; Diazoxide; Diazoxide choline; Diazoxide choline controlled-release tablet; EU/1/06/362/003: 5µg (1 pen); Eutropin; Exenatide; FE 992097; Fluimucil; Fluimucil (acetylcysteine); GENOTONORM; 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.; GLWL-01; Genotonorm; Genotonorm Miniquick 0,2 mg; Genotropin; Growth hormone; Growth hormone (Genotonorm® or Omnitrope®); Guanfacine; Guanfacine extended release (GXR); Human growth hormone; Humatrope 6 mg/12 mg/24 mg injektiokuiva-aine ja liuotin, liuosta varten; INN Not yet proposed; Intranasal Oxytocin (IN-OXT); Intranasal carbetocin Dose 1; Intranasal carbetocin Dose 2; Intranasal oxytocin; LIRAGLUTIDE; Liraglutide; Livoletide; METOPROLOL SUCCINATE; Medical Air vs Oxygen; Medical air; Metoprolol; Metoprololsuccinat Orion 25mg; Metoprololsuccinat ”Orion” 25mg; Metyrapone; Norditropin SimpleXx; Nutropin AQ; OMNITROPE; OT; OXYTOCIN; Octreotide; Omnitrope; Other: Control; Other: Low dose (1 mcg) ACTH stimulation test; Other: Overnight metyrapone test; Oxygen; Oxytocin; Oxytocin (OXT) continuous; Physiological serum (Sodium chloride); Pitolisant; Pitolisant oral tablets; Probiotic; Procedure: DEXA, blood tests, H.G.P.O, osseous age.; Procedure: biopsy; R05CB01; RECOMBINANT HUMAN GROWTH HORMON; RECOMBINANT HUMAN GROWTH HORMONE; RM-493; Recombinant Human Growth Hormone (rhGH) Injection; Recombinant Somatropin; Recombinant human growth hormone; RhGH; Rimonabant; SOMATROPIN; Sandostatin LAR; Saxenda; Sodium chloride; Somatropin; Subcutaneous Beloranib in Suspension; Syntocinon; Syntocinon nasal spray; Syntocinon®/- Spray; TESOFENSINE; Tesofensine; Tesofensine/Metoprolol; Topiramate; ZGN-440; ZGN-440 for Injectable Suspension; ZGN-440 sterile diluent; [AZP-531]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03149445 (ClinicalTrials.gov)	March 30, 2017	3/4/2017	Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)	A 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)	Confirmed Genetic Diagnosis of Prader-Willi Syndrome	Drug: Tesofensine /Metoprolol;Drug: Placebos	Saniona	NULL	Completed	18 Years	30 Years	All	18	Phase 2	Czechia
2	EUCTR2016-003694-18-CZ (EUCTR)	18/01/2017	04/10/2016	Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndrome	A 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/S	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 2	Hungary;Czech Republic
3	EUCTR2016-003694-18-HU (EUCTR)	22/12/2016	13/10/2016	Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndrome	A 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) A 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]		Saniona A/S	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 2	Czech Republic;Hungary

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03149445
(ClinicalTrials.gov)

March 30, 2017

3/4/2017

Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)

A 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)

Confirmed Genetic Diagnosis of Prader-Willi Syndrome

Drug: Tesofensine /Metoprolol;Drug: Placebos

Saniona

NULL

Completed

18 Years

30 Years

All

Phase 2

Czechia

EUCTR2016-003694-18-CZ
(EUCTR)

18/01/2017

04/10/2016

Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndrome

A 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/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic

EUCTR2016-003694-18-HU
(EUCTR)

22/12/2016

13/10/2016

Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndrome

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]

Saniona A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary