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
206	脆弱X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	EUCTR2015-005460-42-ES (EUCTR)	07/07/2016	20/04/2016	Clinical trial to evaluate ascorbic acid (vitamin C) and tocopherol (vitamin E) in combination versus placebo for the treatment of cognitive and behavioral disorders in children with fragile x syndrome	Phase III clinical trial, double-blind, cross-way, to evaluate the safety and efficacy ascorbic acid (vitamin C) and tocopherol (vitamin E) combination versus placebo for the treatment of cognitive and behavioral disorders in children with fragile x syndrome	Fragile x syndrome MedDRA version: 19.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Vitamin C INN or Proposed INN: Vitamin C Other descriptive name: ACIDUM ASCORBICUM D6 Product Name: Vitamin E INN or Proposed INN: Vitamin E Other descriptive name: TOCOPHERYL ACETATE	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	NULL	Not Recruiting			Female: no Male: yes		Phase 3	Spain

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

EUCTR2015-005460-42-ES
(EUCTR)

07/07/2016

20/04/2016

Clinical trial to evaluate ascorbic acid (vitamin C) and tocopherol (vitamin E) in combination versus placebo for the treatment of cognitive and behavioral disorders in children with fragile x syndrome

Phase III clinical trial, double-blind, cross-way, to evaluate the safety and efficacy ascorbic acid (vitamin C) and tocopherol (vitamin E) combination versus placebo for the treatment of cognitive and behavioral disorders in children with fragile x syndrome

Fragile x syndrome
MedDRA version: 19.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Vitamin C
INN or Proposed INN: Vitamin C
Other descriptive name: ACIDUM ASCORBICUM D6
Product Name: Vitamin E
INN or Proposed INN: Vitamin E
Other descriptive name: TOCOPHERYL ACETATE

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

NULL

Not Recruiting

Female: no
Male: yes

Phase 3

Spain