206. 脆弱Ｘ症候群 Fragile X syndrome Clinical trials / Disease details
臨床試験数 : 104 / 薬物数 : 87 - (DrugBank : 32) / 標的遺伝子数 : 54 - 標的パスウェイ数 : 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 | NCT02920892 (ClinicalTrials.gov) | August 17, 2017 | 28/9/2016 | AFQ056 for Language Learning in Children With FXS | Effects of AFQ056 on Language Learning in Young Children With Fragile X Syndrome (FXS) | Fragile X Syndrome | Drug: AFQ056;Other: Placebo;Other: Language Intervention | Elizabeth Berry-Kravis | National Institute of Neurological Disorders and Stroke (NINDS) | Active, not recruiting | 32 Months | 6 Years | All | 99 | Phase 2 | United States |
| 2 | EUCTR2011-002379-40-BE (EUCTR) | 02/12/2013 | 24/10/2013 | Long-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Spain;Indonesia;Turkey;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2011-002379-40-NL (EUCTR) | 08/07/2013 | 08/05/2013 | Long-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Brazil;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 4 | EUCTR2010-022638-96-NL (EUCTR) | 08/07/2013 | 08/05/2013 | Safety and efficacy of AFQ056 in adolescent patients with Fragile X Syndrome | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Brazil;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 5 | EUCTR2010-022638-96-BE (EUCTR) | 27/05/2013 | 18/04/2013 | Safety and efficacy of AFQ056 in adolescent patients with Fragile X Syndrome | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 6 | EUCTR2011-002379-40-FR (EUCTR) | 27/06/2012 | 24/08/2012 | Long-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | ||
| 7 | EUCTR2011-004867-65-ES (EUCTR) | 25/05/2012 | 29/03/2012 | Clinical study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in children with Fragile X Syndrome | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Spain;United States | |||
| 8 | EUCTR2011-002379-40-ES (EUCTR) | 25/05/2012 | 22/02/2012 | Long-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.A | NULL | Not Recruiting | Female: yes Male: yes | 180 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Australia;Denmark;Germany;Netherlands;Sweden | |||
| 9 | EUCTR2011-002379-40-GB (EUCTR) | 24/04/2012 | 12/01/2012 | Long-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden | ||
| 10 | EUCTR2011-002379-40-DK (EUCTR) | 28/03/2012 | 28/02/2012 | Long-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Brazil;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 11 | EUCTR2011-001952-12-FR (EUCTR) | 21/03/2012 | 01/09/2011 | Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X Syndrome | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;France;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Switzerland | ||
| 12 | EUCTR2011-002379-40-IT (EUCTR) | 19/03/2012 | 02/03/2012 | Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome | 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: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 180 | United States;Belgium;Spain;Australia;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | |||
| 13 | EUCTR2011-001952-12-ES (EUCTR) | 08/03/2012 | 01/02/2012 | Seguridad, tolerabilidad y eficacia a largo plazo de AFQ056 en pacientes adultos con síndrome X frágil | Estudio 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.A | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;France;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Switzerland;Italy | ||
| 14 | NCT01482143 (ClinicalTrials.gov) | March 2012 | 21/11/2011 | Clinical 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 Syndrome | Drug: AFQ056 | Novartis Pharmaceuticals | NULL | Completed | 3 Years | 11 Years | All | 21 | Phase 1 | United States;Spain;Switzerland |
| 15 | EUCTR2011-002379-40-DE (EUCTR) | 09/02/2012 | 13/12/2011 | Long-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | France;United States;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden | |||
| 16 | EUCTR2011-002379-40-SE (EUCTR) | 09/01/2012 | 14/11/2011 | Long-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | United States;France;Belgium;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy;Switzerland;Sweden | |||
| 17 | EUCTR2010-022638-96-ES (EUCTR) | 01/12/2011 | 18/10/2011 | Seguridad 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.A | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;France;Belgium;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 18 | EUCTR2011-001952-12-IT (EUCTR) | 14/11/2011 | 06/03/2012 | Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X Syndrome | An 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Switzerland;Italy | |||
| 19 | EUCTR2011-001952-12-DK (EUCTR) | 08/11/2011 | 14/10/2011 | Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X Syndrome | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;France;Canada;Spain;Australia;Denmark;Germany;United Kingdom;Switzerland;Italy | |||
| 20 | EUCTR2011-001952-12-GB (EUCTR) | 07/11/2011 | 21/09/2011 | Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X Syndrome | An 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] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Spain;Denmark;Australia;Germany;Italy;Switzerland;United Kingdom | ||
| 21 | EUCTR2011-001952-12-DE (EUCTR) | 03/11/2011 | 08/08/2011 | Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X Syndrome | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;France;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Switzerland;Italy | |||
| 22 | NCT01433354 (ClinicalTrials.gov) | November 2011 | 31/8/2011 | Long-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 | Drug: AFQ056 | Novartis Pharmaceuticals | NULL | Terminated | 12 Years | 18 Years | All | 119 | Phase 2/Phase 3 | United States;Australia;Belgium;Denmark;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Brazil;Canada;Turkey |
| 23 | EUCTR2009-013667-19-ES (EUCTR) | 06/10/2011 | 11/08/2011 | Seguridad 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.A | NULL | Not Recruiting | Female: yes Male: yes | 160 | France;United States;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Switzerland | |||
| 24 | NCT01348087 (ClinicalTrials.gov) | August 2011 | 3/5/2011 | Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X Syndrome | An Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome | Fragile X Syndrome | Drug: AFQ056 | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 148 | Phase 2 | United States;Australia;Canada;Denmark;France;Germany;Italy;Spain;Switzerland;United Kingdom;Brazil;Netherlands |
| 25 | EUCTR2010-022638-96-IT (EUCTR) | 11/07/2011 | 20/03/2012 | A study to evaluate the efficacy of AFQ056 in treating abnormal behaviors showed by adolescents (12-17 year-old) with Fragile X Syndrome | A 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 180 | United States;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | |||
| 26 | EUCTR2010-022638-96-GB (EUCTR) | 15/06/2011 | 21/02/2011 | Safety and efficacy of AFQ056in adolescent patients with Fragile X Syndrome | A 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 | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Sweden;Germany;Netherlands;Denmark;Australia | ||
| 27 | EUCTR2010-022638-96-SE (EUCTR) | 13/06/2011 | 04/04/2011 | Safety and efficacy of AFQ056 in adolescent patients with Fragile X Syndrome | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | France;United States;Spain;Denmark;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden | |||
| 28 | NCT01357239 (ClinicalTrials.gov) | May 2011 | 18/5/2011 | Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome | A 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 | Drug: AFQ056;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 12 Years | 17 Years | All | 139 | Phase 2 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Indonesia;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;Turkey;United Kingdom;Brazil |
| 29 | EUCTR2010-022638-96-DK (EUCTR) | 27/04/2011 | 18/04/2011 | Safety and efficacy of AFQ056 in adolescent patients with Fragile X Syndrome | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | |||
| 30 | EUCTR2009-013667-19-DE (EUCTR) | 29/12/2010 | 02/11/2010 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | France;United States;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Switzerland | |||
| 31 | EUCTR2009-013667-19-IT (EUCTR) | 22/12/2010 | 24/12/2010 | A randomized, double-blind, placebo-controlled, parallel group study to evaluate AFQ056 in adult patients with Fragile X Syndrome - ND | A 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 160 | Spain;Denmark;Germany;United Kingdom;Italy | |||
| 32 | EUCTR2009-013667-19-GB (EUCTR) | 15/12/2010 | 20/10/2010 | 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] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Denmark;Australia;Germany;Italy;Switzerland;United Kingdom | ||
| 33 | EUCTR2009-013667-19-DK (EUCTR) | 16/11/2010 | 22/09/2010 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | France;United States;Canada;Spain;Australia;Denmark;Germany;Italy;United Kingdom;Switzerland | |||
| 34 | NCT01253629 (ClinicalTrials.gov) | November 2010 | 2/12/2010 | 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 | Drug: AFQ056;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 45 Years | All | 175 | Phase 2 | United States;Australia;Canada;Denmark;France;Germany;Italy;Spain;Switzerland;United Kingdom |
| 35 | EUCTR2007-005088-82-IT (EUCTR) | 11/06/2008 | 09/04/2008 | A 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 | A 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 FARMA | NULL | Not Recruiting | Female: no Male: yes | 30 | France;Italy | |||
| 36 | NCT00718341 (ClinicalTrials.gov) | June 2008 | 17/7/2008 | Efficacy, Safety and Tolerability of AFQ056 in Fragile X Patients | A 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 | Fragile X Syndrome | Drug: AF056;Drug: Placebo | Novartis | NULL | Completed | 18 Years | 35 Years | Male | 30 | Phase 2 | France;Italy;Switzerland |
| 37 | EUCTR2007-005088-82-FR (EUCTR) | 15/05/2008 | 20/11/2007 | A 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 | A 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 AG | NULL | Not Recruiting | Female: no Male: yes | 30 | France;Italy | |||
| 38 | EUCTR2010-022638-96-FR (EUCTR) | 12/04/2011 | A study to evaluate the efficacy of AFQ056 in treating abnormal behaviors showed by adolescents (12-17 year-old) with Fragile X Syndrome | A 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 AG | NULL | NA | Female: yes Male: yes | 180 | Phase 2 | United States;France;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden | |||
| 39 | EUCTR2011-002379-40-Outside-EU/EEA (EUCTR) | 15/12/2011 | Long-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 AG | NULL | NA | Female: yes Male: yes | 180 | Australia;Switzerland;United States | ||||
| 40 | EUCTR2010-022638-96-DE (EUCTR) | 26/04/2011 | Safety and efficacy of AFQ056 in adolescent patients with Fragile X Syndrome | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Australia;Denmark;Germany;Netherlands;Sweden | ||||
| 41 | EUCTR2010-022638-96-Outside-EU/EEA (EUCTR) | 31/10/2011 | Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome | A 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 AG | NULL | NA | Female: yes Male: yes | 160 | Australia;United States | ||||
| 42 | EUCTR2010-019353-18-Outside-EU/EEA (EUCTR) | 31/10/2011 | Two-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 AG | NULL | NA | Female: no Male: yes | 12 | Switzerland | ||||
| 43 | EUCTR2011-004867-65-Outside-EU/EEA (EUCTR) | 29/02/2012 | Clinical study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in children with Fragile X Syndrome | 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 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 AG | NULL | NA | Female: yes Male: yes | 24 | Spain;United States |