206. Fragile X syndrome Clinical trials / Disease details
Clinical trials : 104 / Drugs : 87 - (DrugBank : 32) / Drug target genes : 54 - Drug target pathways : 79
| 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 | NCT01750957 (ClinicalTrials.gov) | February 2013 | 11/12/2012 | A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome | A Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Safety and Exploratory Efficacy and Pharmacokinetic, Study of RO4917523 in Pediatric Patients With Fragile X Syndrome | Fragile X Syndrome | Drug: Placebo;Drug: RO4917523 | Hoffmann-La Roche | NULL | Completed | 5 Years | 13 Years | Both | 47 | Phase 2 | United States |
| 2 | EUCTR2011-004349-42-ES (EUCTR) | 16/08/2012 | 21/05/2012 | A study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome | A randomized, double-blind, 12- week, parallel group, placebo-controlled study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome. | Fragile X Syndrome (FXS) MedDRA version: 14.1;Level: LLT;Classification code 10025463;Term: Major depressive disorder, single episode;System Organ Class: 10037175 - Psychiatric disorders;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03] | Product Name: mGlu5 antagonist Product Code: Ro 491-7523/F18 Other descriptive name: mGlu5 antagonist Product Name: mGlu5 antagonist Product Code: Ro 491-7523/F19 Other descriptive name: mGlu5 antagonist | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | France;United States;Mexico;Canada;Argentina;Spain;Peru;Chile;United Kingdom;Sweden | |||
| 3 | EUCTR2011-004349-42-GB (EUCTR) | 16/07/2012 | 25/04/2012 | A study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome | A randomized, double-blind, 12- week, parallel group, placebo-controlled study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome. | Fragile X Syndrome (FXS) MedDRA version: 14.1;Level: LLT;Classification code 10025463;Term: Major depressive disorder, single episode;System Organ Class: 100000004873;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03] | Product Name: mGlu5 antagonist Product Code: Ro 491-7523/F18 Other descriptive name: mGlu5 antagonist Product Name: mGlu5 antagonist Product Code: Ro 491-7523/F19 Other descriptive name: mGlu5 antagonist | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;France;Mexico;Canada;Argentina;Spain;Peru;Chile;United Kingdom;Sweden | ||
| 4 | EUCTR2011-004349-42-SE (EUCTR) | 29/06/2012 | 02/05/2012 | A study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome | A randomized, double-blind, 12- week, parallel group, placebo-controlled study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome. | Fragile X Syndrome (FXS) MedDRA version: 14.1;Level: LLT;Classification code 10025463;Term: Major depressive disorder, single episode;System Organ Class: 100000004873;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03] | Product Name: mGlu5 antagonist Product Code: Ro 491-7523/F18 Other descriptive name: mGlu5 antagonist Product Name: mGlu5 antagonist Product Code: Ro 491-7523/F19 Other descriptive name: mGlu5 antagonist | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | France;United States;Mexico;Canada;Argentina;Spain;Peru;Chile;United Kingdom;Sweden | |||
| 5 | NCT01517698 (ClinicalTrials.gov) | May 2012 | 20/1/2012 | A Study of RO4917523 in Patients With Fragile X Syndrome | A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome. | Fragile X Syndrome | Drug: Placebo;Drug: RO4917523 0.5 mg;Drug: RO4917523 1.5 mg | Hoffmann-La Roche | NULL | Completed | 14 Years | 50 Years | Both | 185 | Phase 2 | United States;Argentina;Canada;Chile;France;Mexico;Peru;Spain;Sweden;United Kingdom |
| 6 | NCT01015430 (ClinicalTrials.gov) | November 2009 | 17/11/2009 | A Study With RO4917523 in Patients With Fragile X Syndrome | A Randomized, Double-blind, Placebo-controlled, Pharmacokinetic, Safety and Tolerability, and Exploratory Efficacy and Pharmacodynamic Effects Study of RO4917523 in Adult Patients With Fragile X Syndrome. | Fragile X Syndrome | Drug: Placebo (for RO4917523 ascending doses);Drug: Placebo (for RO4917523 fixed dose);Drug: RO4917523 | Hoffmann-La Roche | NULL | Completed | 18 Years | 50 Years | Both | 40 | Phase 2 | United States |