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	NCT01325220 (ClinicalTrials.gov)	June 2011	28/3/2011	Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome	A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Children With Fragile X Syndrome	Fragile X Syndrome	Drug: arbaclofen;Drug: Placebo	Seaside Therapeutics, Inc.	NULL	Completed	5 Years	11 Years	Both	172	Phase 3	United States
2	NCT01282268 (ClinicalTrials.gov)	May 2011	20/1/2011	Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome	A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Adolescents and Adults With Fragile X Syndrome	Fragile X Syndrome	Drug: arbaclofen;Drug: placebo	Seaside Therapeutics, Inc.	NULL	Completed	12 Years	50 Years	Both	125	Phase 3	United States
3	NCT01013480 (ClinicalTrials.gov)	November 2009	12/11/2009	An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome	An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Fragile X Syndrome	Fragile X Syndrome	Drug: Arbaclofen	Seaside Therapeutics, Inc.	NULL	Terminated	6 Years	40 Years	Both	45	Phase 2	United States
4	NCT00892580 (ClinicalTrials.gov)	May 2009	1/5/2009	Biomarker and DNA Collection in Subjects Participating in Protocol 22003	Biomarker Testing and DNA Collection in Subjects Participating in an Open-Label, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Autism Spectrum Disorders	Fragile X Syndrome	Drug: STX209	Seaside Therapeutics, Inc.	NULL	Completed	6 Years	17 Years	Both	32	N/A	United States
5	NCT00823368 (ClinicalTrials.gov)	January 2009	13/1/2009	Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001	Biomarker Testing and DNA Collection in Subjects Participating in a Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X Syndrome	Fragile X Syndrome	Drug: STX209	Seaside Therapeutics, Inc.	NULL	Completed	6 Years	40 Years	Both		N/A	United States
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
6	NCT00788073 (ClinicalTrials.gov)	November 2008	7/11/2008	Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome	A Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X Syndrome	Fragile X Syndrome	Drug: STX209;Drug: Placebo	Seaside Therapeutics, Inc.	NULL	Completed	6 Years	40 Years	All	63	Phase 2	United States

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

NCT01325220
(ClinicalTrials.gov)

June 2011

28/3/2011

Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome

A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Children With Fragile X Syndrome

Fragile X Syndrome

Drug: arbaclofen;Drug: Placebo

Seaside Therapeutics, Inc.

NULL

Completed

5 Years

11 Years

Both

172

Phase 3

United States

NCT01282268
(ClinicalTrials.gov)

May 2011

20/1/2011

Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Adolescents and Adults With Fragile X Syndrome

Fragile X Syndrome

Drug: arbaclofen;Drug: placebo

Seaside Therapeutics, Inc.

NULL

Completed

12 Years

50 Years

Both

125

Phase 3

United States

NCT01013480
(ClinicalTrials.gov)

November 2009

12/11/2009

An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome

An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Fragile X Syndrome

Fragile X Syndrome

Drug: Arbaclofen

Seaside Therapeutics, Inc.

NULL

Terminated

6 Years

40 Years

Both

Phase 2

United States

NCT00892580
(ClinicalTrials.gov)

May 2009

1/5/2009

Biomarker and DNA Collection in Subjects Participating in Protocol 22003

Biomarker Testing and DNA Collection in Subjects Participating in an Open-Label, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Autism Spectrum Disorders

Fragile X Syndrome

Drug: STX209

Seaside Therapeutics, Inc.

NULL

Completed

6 Years

17 Years

Both

N/A

United States

NCT00823368
(ClinicalTrials.gov)

January 2009

13/1/2009

Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001

Biomarker Testing and DNA Collection in Subjects Participating in a Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X Syndrome

Fragile X Syndrome

Drug: STX209

Seaside Therapeutics, Inc.

NULL

Completed

6 Years

40 Years

Both

N/A

United States

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

NCT00788073
(ClinicalTrials.gov)

November 2008

7/11/2008

Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome

A Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X Syndrome

Fragile X Syndrome

Drug: STX209;Drug: Placebo

Seaside Therapeutics, Inc.

NULL

Completed

6 Years

40 Years

All

Phase 2

United States