206. 脆弱X症候群 Fragile X syndrome Clinical trials / Disease details


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

  
6 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2011-002379-40-BE
(EUCTR)
02/12/201324/10/2013Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label)An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: Mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: Mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Spain;Indonesia;Turkey;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Sweden
2EUCTR2011-002379-40-NL
(EUCTR)
08/07/201308/05/2013Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label)An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X syndrome
MedDRA version: 16.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: Mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: Mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Brazil;Australia;Denmark;Netherlands;Germany;Sweden
3EUCTR2010-022638-96-NL
(EUCTR)
08/07/201308/05/2013Safety and efficacy of AFQ056 in adolescent patients with Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 16.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Brazil;Australia;Denmark;Netherlands;Germany;Sweden
4EUCTR2010-022638-96-BE
(EUCTR)
27/05/201318/04/2013Safety and efficacy of AFQ056 in adolescent patients with Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety ofAFQ056 in adolescent patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: Mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: Mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Sweden
5EUCTR2010-022638-96-Outside-EU/EEA
(EUCTR)
31/10/2011Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of AFQ056 in adolescent patients with Fragile X Syndrome - Fragile X Syndrome
MedDRA version: 14.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
160Australia;United States
6EUCTR2010-019353-18-Outside-EU/EEA
(EUCTR)
31/10/2011Two-period, single-dose pharmacokinetic study in male adolescent patients with Fragile X Syndrome (FXS).A sequential, open-label, two-period study to assess the pharmacokinetics, safety and tolerability of two dose levels of AFQ056 in male, adolescent patients with Fragile X Syndrome (12 to 18 years inclusive) Fragile X Syndrome
MedDRA version: 14.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Novartis Pharma Services AGNULLNAFemale: no
Male: yes
12Switzerland