DDrare: Database of Drug Development for Rare Diseases

Searched query = "Fragile X 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 = 11C-flumazenil; 18F-FTC-146; ACIDUM ASCORBICUM D6; AF056; AFQ056; AZD7325; AZD7325 (High-Dose); AZD7325 (Low-Dose); Acamprosate; Acetate; Acidum ascorbicum; Alpha-tocopherol; Ampalex; Arbaclofen; Aripiprazole; Ascorbic Acid (Vitamin C) and Alpha-tocopherol (Vitamin E); Ascorbic acid; BPN14770; CBD; CCD 1042, MD 9150000, Mepalon 1042, SPT316; CX516; CX516 (Ampalex®); Donepezil; EGCG; EGCG FontUp; Flumazenil; Fluoxetin; GANAXOLONE; Gaboxadol; Ganaxolone; Lovastatin; Lovastatin, then Minocycline/Lovastatin; MG01CI extended-release tablet; MGlu5 antagonist; Mavoglurant; Metformin; Methylphenidate; Methylphenidate, fluoxetin, risperidone; Minocycline; Minocycline hydrochloride; Minocycline, then Minocycline/Lovastatin; NNZ-2566; NPL-2009; OV101; OV101 (gaboxadol); Other: Biological samples; Other: Cognitive training; Other: Language Intervention; Other: MRI; Oxytocin; Oxytocin 24IU; Oxytocin 48IU; RO4917523; RO4917523 0.5 mg; RO4917523 1.5 mg; Riluzole; Risperidone; Ro 491-7523/F18; Ro 491-7523/F19; STX107; STX209; Sertraline; Sugar pill; TOCOPHERYL ACETATE; Tocopherol; Tocopheryl acetate; Vitamin C; Vitamin C 10mg/Kg Vitamin E 10 mg/Kg; Vitamin E; ZYN002 - CBD Transdermal Gel; [18F]FPEB; [18F]FPEB PET imaging; [18F]flumazenil

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
2	NCT02942498 (ClinicalTrials.gov)	July 2016	7/10/2016	Clinical Trial for Asses the Safety and Efficacy of Vitamin C and Vitamin E in Combination Versus Placebo for Treating Cognitive and Behavior Disorder in Children With Fragile X Syndrome	Clinical Trials Phase III, Double Blind, Crossover to Asses the Safety and Efficacy of Vitamin C and Vitamin E in Combination Versus Placebo for Treating Cognitive and Behavior Disorder in Children With Fragile X Syndrome	X Fragile Syndrome	Drug: Vitamin C 10mg/Kg Vitamin E 10 mg/Kg;Drug: Placebo	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	Delos Clinical	Recruiting	1 Year	8 Years	Both	40	Phase 3	Spain
3	NCT01329770 (ClinicalTrials.gov)	December 2010	29/3/2011	Safety and Efficacy Study of Antioxidants for the Treatment of the Fragile X Syndrome	Phase II Double-blind Randomized Placebo-controlled 1-way Crossover Trial to Investigate Safety and Efficacy of the Ascorbic Acid and Tocopherol for the Treatment of the Fragile X Syndrome	Fragile X Syndrome	Dietary Supplement: Ascorbic Acid (Vitamin C) and Alpha-tocopherol (Vitamin E);Dietary Supplement: Placebo	Yolanda de Diego Otero	NULL	Completed	6 Years	18 Years	Male	30	Phase 2	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

NCT02942498
(ClinicalTrials.gov)

July 2016

7/10/2016

Clinical Trial for Asses the Safety and Efficacy of Vitamin C and Vitamin E in Combination Versus Placebo for Treating Cognitive and Behavior Disorder in Children With Fragile X Syndrome

Clinical Trials Phase III, Double Blind, Crossover to Asses the Safety and Efficacy of Vitamin C and Vitamin E in Combination Versus Placebo for Treating Cognitive and Behavior Disorder in Children With Fragile X Syndrome

X Fragile Syndrome

Drug: Vitamin C 10mg/Kg Vitamin E 10 mg/Kg;Drug: Placebo

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

Delos Clinical

Recruiting

1 Year

8 Years

Both

Phase 3

Spain

NCT01329770
(ClinicalTrials.gov)

December 2010

29/3/2011

Safety and Efficacy Study of Antioxidants for the Treatment of the Fragile X Syndrome

Phase II Double-blind Randomized Placebo-controlled 1-way Crossover Trial to Investigate Safety and Efficacy of the Ascorbic Acid and Tocopherol for the Treatment of the Fragile X Syndrome

Fragile X Syndrome

Dietary Supplement: Ascorbic Acid (Vitamin C) and Alpha-tocopherol (Vitamin E);Dietary Supplement: Placebo

Yolanda de Diego Otero

NULL

Completed

6 Years

18 Years

Male

Phase 2

Spain