206. 脆弱X症候群
[臨床試験数:98,薬物数:73(DrugBank:27),標的遺伝子数:46,標的パスウェイ数:57

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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
43 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02920892
(ClinicalTrials.gov)
August 17, 201728/9/2016AFQ056 for Language Learning in Children With FXSEffects of AFQ056 on Language Learning in Young Children With Fragile X Syndrome (FXS)Fragile X SyndromeDrug: AFQ056;Other: Placebo;Other: Language InterventionElizabeth Berry-KravisNational Institute of Neurological Disorders and Stroke (NINDS)Active, not recruiting32 Months6 YearsAll99Phase 2United States
2EUCTR2011-002379-40-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
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
4EUCTR2011-002379-40-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
5EUCTR2010-022638-96-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2011-002379-40-FR
(EUCTR)
27/06/201224/08/2012Long-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: 15.0;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
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
7EUCTR2011-002379-40-ES
(EUCTR)
25/05/201222/02/2012Long-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
Product Name: AFQ056
Product Code: AFQ056
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
180United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Australia;Denmark;Germany;Netherlands;Sweden
8EUCTR2011-004867-65-ES
(EUCTR)
25/05/201229/03/2012Clinical study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in children with Fragile X SyndromeSequential, two-period study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in patients with FXS (Fragile X syndrome) aged 5-11 years (Cohort 1) and 3-4 years (Cohort 2) 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
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Spain;United States
9EUCTR2011-002379-40-GB
(EUCTR)
24/04/201212/01/2012Long-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]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
180Phase 2France;United States;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden
10EUCTR2011-002379-40-DK
(EUCTR)
28/03/201228/02/2012Long-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: 16.1;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
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Brazil;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2011-001952-12-FR
(EUCTR)
21/03/201201/09/2011Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X SyndromeAn open-label study to evaluate the long-term safety, tolerability and efficacy of AFQ056 in adult 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: Psychiatry and Psychology [F] - Mental Disorders [F03]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;France;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Switzerland
12EUCTR2011-002379-40-IT
(EUCTR)
19/03/201202/03/2012Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X SyndromeAn 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: NA
Other descriptive name: NA
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
180United States;Belgium;Spain;Australia;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
13EUCTR2011-001952-12-ES
(EUCTR)
08/03/201201/02/2012Seguridad, tolerabilidad y eficacia a largo plazo de AFQ056 en pacientes adultos con síndrome X frágilEstudio abierto para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de AFQ056 en pacientes adultos con síndrome X frágil 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
Product Name: AFQ056
Product Code: AFQ056
Novartis Farmacéutica S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200United Kingdom;Germany;Canada;Switzerland;Denmark;France;Spain;Italy;United States;Australia
14NCT01482143
(ClinicalTrials.gov)
March 201221/11/2011Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of AFQ056 in Children With Fragile X Syndrome (FXS)Sequential, Two-period Study to Assess the Pharmacokinetics, Safety & Tolerability of Single and Multiple Oral Doses of AFQ056 in Patients With FXS (Fragile X Syndrome) Aged 5-11 Years (Cohort 1) and 3-4 Years (Cohort 2)Fragile X SyndromeDrug: AFQ056Novartis PharmaceuticalsNULLCompleted3 Years11 YearsAll21Phase 1United States;Spain;Switzerland
15EUCTR2011-002379-40-DE
(EUCTR)
09/02/201213/12/2011Long-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
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180France;United States;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2011-002379-40-SE
(EUCTR)
09/01/201214/11/2011Long-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: 16.1;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
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180United States;France;Belgium;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy;Switzerland;Sweden
17EUCTR2010-022638-96-ES
(EUCTR)
01/12/201118/10/2011Seguridad y eficacia de AFQ056 en pacientes adolescentes con Síndrome X Frágil.Estudio aleatorizado, doble ciego, controlado con placebo, con grupos paralelos para evaluar la eficacia y seguridad de AFQ056 en pacientes adolescentes con síndrome X frágil - Síndrome X Frágil
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
Product Name: AFQ056
Product Code: AFQ056
Novartis Farmacéutica S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160United Kingdom;Germany;Switzerland;Denmark;France;Spain;Italy;United States;Sweden;Australia
18EUCTR2011-001952-12-IT
(EUCTR)
14/11/201106/03/2012Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X SyndromeAn open-label study to evaluate the long-term safety, tolerability and efficacy of AFQ056 in adult 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: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
200United States;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Switzerland;Italy
19EUCTR2011-001952-12-DK
(EUCTR)
08/11/201114/10/2011Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X SyndromeAn open-label study to evaluate the long-term safety, tolerability and efficacy of AFQ056 in adult 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
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United States;France;Canada;Spain;Australia;Denmark;Germany;United Kingdom;Switzerland;Italy
20EUCTR2011-001952-12-GB
(EUCTR)
07/11/201121/09/2011 Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X SyndromeAn open-label study to evaluate the long-term safety, tolerability and efficacy of AFQ056 in adult patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 16.1;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]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
200Phase 2United States;France;Canada;Spain;Denmark;Australia;Germany;Italy;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2011-001952-12-DE
(EUCTR)
03/11/201108/08/2011Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X SyndromeAn open-label study to evaluate the long-term safety, tolerability and efficacy of AFQ056 in adult 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
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United States;France;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Switzerland;Italy
22NCT01433354
(ClinicalTrials.gov)
November 201131/8/2011Long-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 SyndromeFragile X SyndromeDrug: AFQ056Novartis PharmaceuticalsNULLTerminated12 Years18 YearsAll119Phase 2;Phase 3United States;Australia;Belgium;Denmark;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Brazil;Canada;Turkey
23EUCTR2009-013667-19-ES
(EUCTR)
06/10/201111/08/2011Seguridad y eficacia de AFQ056 en pacientes adultos con Síndrome X Frágil.Estudio aleatorizado, doble ciego, controlado con placebo, con grupos paralelos para evaluar AFQ056 en pacientes adultos con síndrome X frágil Síndrome X Frágil
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
Product Name: AFQ056
Product Code: AFQ056
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
160France;United States;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Switzerland
24NCT01348087
(ClinicalTrials.gov)
August 20113/5/2011Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X SyndromeAn Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of AFQ056 in Adult Patients With Fragile X SyndromeFragile X SyndromeDrug: AFQ056Novartis PharmaceuticalsNULLTerminated18 YearsN/AAll148Phase 2United States;Australia;Canada;Denmark;France;Germany;Italy;Spain;Switzerland;United Kingdom;Brazil;Netherlands
25EUCTR2010-022638-96-IT
(EUCTR)
11/07/201120/03/2012A study to evaluate the efficacy of AFQ056 in treating abnormal behaviors showed by adolescents (12-17 year-old) 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: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: AFQ056
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: AFQ056
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
180United States;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2010-022638-96-GB
(EUCTR)
15/06/201121/02/2011Safety and efficacy of AFQ056in 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: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
160Phase 2United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
27EUCTR2010-022638-96-SE
(EUCTR)
13/06/201104/04/2011Safety 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 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
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
160France;United States;Spain;Denmark;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
28NCT01357239
(ClinicalTrials.gov)
May 201118/5/2011Safety 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 SyndromeFragile X SyndromeDrug: AFQ056;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted12 Years17 YearsAll139Phase 2United States;Australia;Belgium;Canada;Denmark;France;Germany;Indonesia;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;Turkey;United Kingdom;Brazil
29EUCTR2010-022638-96-DK
(EUCTR)
27/04/201118/04/2011Safety 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 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
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
30EUCTR2009-013667-19-DE
(EUCTR)
29/12/201002/11/2010Safety and Efficacy of AFQ056 in Adult Patients With Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate AFQ056 in adult patientswith Fragile X Syndrome Fragile X Syndrome
MedDRA version: 15.0;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
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
160France;United States;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2009-013667-19-IT
(EUCTR)
22/12/201024/12/2010A randomized, double-blind, placebo-controlled, parallel group study to evaluate AFQ056 in adult patients with Fragile X Syndrome - NDA randomized, double-blind, placebo-controlled, parallel group study to evaluate AFQ056 in adult patients with Fragile X Syndrome - ND Fragile X Syndrome
MedDRA version: 9.1;Level: PT;Classification code 10017324
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
160Spain;Denmark;Germany;United Kingdom;Italy
32EUCTR2009-013667-19-GB
(EUCTR)
15/12/201020/10/2010 Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome A randomized, double-blind, placebo-controlled, parallel group study to evaluate AFQ056 in adult 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]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
160Phase 2France;United States;Canada;Spain;Denmark;Australia;Germany;Italy;Switzerland;United Kingdom
33EUCTR2009-013667-19-DK
(EUCTR)
16/11/201022/09/2010Safety and Efficacy of AFQ056 in Adult Patients With Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate AFQ056 in adult patientswith Fragile X Syndrome Fragile X Syndrome
MedDRA version: 15.1;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
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
160France;United States;Canada;Spain;Australia;Denmark;Germany;Italy;United Kingdom;Switzerland
34NCT01253629
(ClinicalTrials.gov)
November 20102/12/2010Safety and Efficacy of AFQ056 in Adult Patients With Fragile X SyndromeA Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate AFQ056 in Adult Patients With Fragile X SyndromeFragile X SyndromeDrug: AFQ056;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years45 YearsAll175Phase 2United States;Australia;Canada;Denmark;France;Germany;Italy;Spain;Switzerland;United Kingdom
35EUCTR2007-005088-82-IT
(EUCTR)
11/06/200809/04/2008A multi-centre, randomized, double-blind, placebo-controlled, two-period, crossover proof-of-concept study in male patients with Fragile X Syndrome to assess the efficacy, safety and tolerability of multiple oral doses of AFQ056 - NDA multi-centre, randomized, double-blind, placebo-controlled, two-period, crossover proof-of-concept study in male patients with Fragile X Syndrome to assess the efficacy, safety and tolerability of multiple oral doses of AFQ056 - ND Fragile X Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10017324;Term: Fragile X syndrome
Product Code: AFQ056
Product Code: AFQ056
NOVARTIS FARMANULLNot RecruitingFemale: no
Male: yes
30France;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT00718341
(ClinicalTrials.gov)
June 200817/7/2008Efficacy, Safety and Tolerability of AFQ056 in Fragile X PatientsA Multi-centre, Randomized, Double-blind, Placebo Controlled, Two-period, Crossover Proof-of-concept Study in Male Patients With Fragile X Syndrome to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of AFQ056Fragile X SyndromeDrug: AF056;Drug: PlaceboNovartisNULLCompleted18 Years35 YearsMale30Phase 2France;Italy;Switzerland
37EUCTR2007-005088-82-FR
(EUCTR)
15/05/200820/11/2007A multi-centre, randomized, double-blind, placebo-controlled, two-period, crossover proof-of-concept study in patients with Fragile X Syndrome to assess the efficacy, safety and tolerability of multiple oral doses of AFQ056A multi-centre, randomized, double-blind, placebo-controlled, two-period, crossover proof-of-concept study in patients with Fragile X Syndrome to assess the efficacy, safety and tolerability of multiple oral doses of AFQ056 Fragile X Syndrome
MedDRA version: 9.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome
Product Code: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: no
Male: yes
30France;Italy
38EUCTR2011-002379-40-Outside-EU/EEA
(EUCTR)
15/12/2011Long-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
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
180Australia;Switzerland;United States
39EUCTR2010-022638-96-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
40EUCTR2010-022638-96-FR
(EUCTR)
12/04/2011A study to evaluate the efficacy of AFQ056 in treating abnormal behaviors showed by adolescents (12-17 year-old) 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: 13.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
180Phase 2United States;France;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2010-022638-96-DE
(EUCTR)
26/04/2011Safety 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 ofAFQ056 in adolescent patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 15.0;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
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
160United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Australia;Denmark;Germany;Netherlands;Sweden
42EUCTR2010-019353-18-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
43EUCTR2011-004867-65-Outside-EU/EEA
(EUCTR)
29/02/2012Clinical study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in children with Fragile X SyndromeSequential, two-period study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in patients with FXS (Fragile X syndrome) aged 5-11 years (Cohort 1) and 3-4 years (Cohort 2) 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
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
24Spain;United States