RO4917523 ( DrugBank: - )


1 disease
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6

206. 脆弱X症候群


臨床試験数 : 108 薬物数 : 91 - (DrugBank : 36) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 77
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01750957
(ClinicalTrials.gov)
February 201311/12/2012A Study of RO4917523 in Pediatric Patients With Fragile X SyndromeA Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Safety and Exploratory Efficacy and Pharmacokinetic, Study of RO4917523 in Pediatric Patients With Fragile X SyndromeFragile X SyndromeDrug: Placebo;Drug: RO4917523Hoffmann-La RocheNULLCompleted5 Years13 YearsBoth47Phase 2United States
2EUCTR2011-004349-42-ES
(EUCTR)
16/08/201221/05/2012A study of the efficacy and safety of RO4917523 in patients with Fragile X SyndromeA 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.NULLNot RecruitingFemale: yes
Male: yes
180France;United States;Mexico;Canada;Argentina;Spain;Peru;Chile;United Kingdom;Sweden
3EUCTR2011-004349-42-GB
(EUCTR)
16/07/201225/04/2012A study of the efficacy and safety of RO4917523 in patients with Fragile X SyndromeA 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.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;France;Mexico;Canada;Argentina;Spain;Peru;Chile;United Kingdom;Sweden
4EUCTR2011-004349-42-SE
(EUCTR)
29/06/201202/05/2012A study of the efficacy and safety of RO4917523 in patients with Fragile X SyndromeA 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.NULLNot RecruitingFemale: yes
Male: yes
180France;United States;Mexico;Canada;Argentina;Spain;Peru;Chile;United Kingdom;Sweden
5NCT01517698
(ClinicalTrials.gov)
May 201220/1/2012A Study of RO4917523 in Patients With Fragile X SyndromeA Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.Fragile X SyndromeDrug: Placebo;Drug: RO4917523 0.5 mg;Drug: RO4917523 1.5 mgHoffmann-La RocheNULLCompleted14 Years50 YearsBoth185Phase 2United States;Argentina;Canada;Chile;France;Mexico;Peru;Spain;Sweden;United Kingdom
6NCT01015430
(ClinicalTrials.gov)
November 200917/11/2009A Study With RO4917523 in Patients With Fragile X SyndromeA 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 SyndromeDrug: Placebo (for RO4917523 ascending doses);Drug: Placebo (for RO4917523 fixed dose);Drug: RO4917523Hoffmann-La RocheNULLCompleted18 Years50 YearsBoth40Phase 2United States