DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
193	プラダー・ウィリ症候群	1

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	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

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

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