206. Fragile X syndrome Clinical trials / Disease details
Clinical trials : 108 / Drugs : 91 - (DrugBank : 36) / Drug target genes : 52 - Drug target pathways : 77
| 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 | |
| 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 |