GANAXOLONE ( DrugBank: Ganaxolone )
4 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 145 | ウエスト症候群 | 5 |
| 152 | ＰＣＤＨ19関連症候群 | 10 |
| 158 | 結節性硬化症 | 3 |
| 206 | 脆弱Ｘ症候群 | 2 |
145. ウエスト症候群
臨床試験数 : 43 / 薬物数 : 52 - (DrugBank : 15) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 26
Showing 1 to 5 of 5 diseases
| 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 | EUCTR2006-004285-13-CZ (EUCTR) | 11/05/2007 | 30/03/2007 | A double-blind, placebo-controlled, dose-ranging clinical study to evaluate the safety, tolerability, and antiepileptic activity of ganaxolone in treatment of patients with infantile spasms. A double-blind, placebo-controlled, dose-ranging clinical study to evaluate the safety, tolerability ... | A double-blind, placebo-controlled, dose-ranging clinical study to evaluate the safety, tolerability, and antiepileptic activity of ganaxolone in treatment of patients with infantile spasms. A double-blind, placebo-controlled, dose-ranging clinical study to evaluate the safety, tolerability ... | Infantile spasms MedDRA version: 9.1;Level: LLT;Classification code 10021750;Term: Infantile spasms | Product Name: Ganaxolone Other descriptive name: Ganaxolone | Marinus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 54 | Czech Republic | |||
| 2 | EUCTR2006-004286-33-CZ (EUCTR) | 11/05/2007 | 30/03/2007 | An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in treatment of patients diagnosed with infantile spasms. An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in tre ... | An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in treatment of patients diagnosed with infantile spasms. An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in tre ... | Infantile spasms MedDRA version: 9.1;Level: LLT;Classification code 10021750;Term: Infantile spasms | Product Name: Ganaxolone Product Code: SPT3162 Other descriptive name: Ganaxolone | Marinus Pharmceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 54 | Czech Republic | |||
| 3 | NCT00442104 (ClinicalTrials.gov) | January 2007 | 27/2/2007 | Open-label Extension to Protocol 1042-0500 | An Open-label Clinical Study to Evaluate the Safety and Antiepileptic Activity of Ganaxolone in Treatment of Patients Diagnosed With Infantile Spasms. An Open-label Clinical Study to Evaluate the Safety and Antiepileptic Activity of Ganaxolonein Treat ... | Infantile Spasms | Drug: Ganaxolone | Marinus Pharmaceuticals | NULL | Terminated | 4 Months | 24 Months | All | 54 | Phase 2 | United States |
| 4 | NCT00441896 (ClinicalTrials.gov) | January 2007 | 27/2/2007 | A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms | A Double-blind, Placebo-controlled, Dose-ranging Clinical Study to Evaluate the Safety, Tolerability, and Antiepileptic Activity of Ganaxolone in Treatment of Patients With Infantile Spasms A Double-blind, Placebo-controlled, Dose-ranging Clinical Study to Evaluate the Safety, Tolerability ... | Infantile Spasms | Drug: Ganaxolone;Other: Placebo | Marinus Pharmaceuticals | NULL | Completed | 4 Months | 24 Months | All | 56 | Phase 2 | United States |
| 5 | EUCTR2006-004286-33-PL (EUCTR) | 04/06/2007 | An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in treatment of patients diagnosed with infantile spansms. An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in tre ... | An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in treatment of patients diagnosed with infantile spansms. An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in tre ... | Infantile spasms MedDRA version: 9.1;Level: LLT;Classification code 10021750;Term: Infantile spasms | Product Name: Ganaxolone Product Code: SPT3162 | Marinus Pharmceuticals, Inc. | NULL | NA | Female: yes Male: yes | 54 | Phase 2 | Czech Republic;Poland |
152. ＰＣＤＨ19関連症候群
臨床試験数 : 10 / 薬物数 : 7 - (DrugBank : 1) / 標的遺伝子数 : 16 - 標的パスウェイ数 : 7
Showing 1 to 10 of 10 diseases
| 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 | EUCTR2018-004496-12-GB (EUCTR) | 14/01/2020 | 18/11/2019 | A clinical study with an investigational drug called ganaxolone in female children with protocadherin 19 (PCDH19)-related epilepsy A clinical study with an investigational drug called ganaxolonein female children with protocadherin ... | A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female children with protocadherin 19 (PCDH19)-related epilepsy followed by long-term open-label treatment A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolonetreatment in female chi ... | protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032061;Term: Other forms of epilepsy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ... | Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT3162 INN or Proposed INN: GANAXOLONE Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT3162 INN or Proposed INN ... | Marinus Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 70 | Phase 3 | United States;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Denmark;Germany;Netherlands United States;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Den ... | ||
| 2 | EUCTR2018-004496-12-HU (EUCTR) | 13/01/2020 | 04/11/2019 | A clinical study with an investigational drug called ganaxolone in female children with protocadherin 19 (PCDH19)-related epilepsy A clinical study with an investigational drug called ganaxolonein female children with protocadherin ... | A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female children with protocadherin 19 (PCDH19)-related epilepsy followed by long-term open-label treatment A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolonetreatment in female chi ... | protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032061;Term: Other forms of epilepsy;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ... | Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT3162 INN or Proposed INN: GANAXOLONE Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT3162 INN or Proposed INN ... | Marinus Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Germany;Netherlands United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Austral ... | ||
| 3 | EUCTR2018-004496-12-FR (EUCTR) | 26/09/2019 | 29/04/2019 | A clinical study with an investigational drug called ganaxolone in female children with protocadherin 19 (PCDH19)-related epilepsy A clinical study with an investigational drug called ganaxolonein female children with protocadherin ... | A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female children with protocadherin 19 (PCDH19)-related epilepsy followed by long-term open-label treatment A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolonetreatment in female chi ... | protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032061;Term: Other forms of epilepsy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ... | Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT316 INN or Proposed INN: GANAXOLONE Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT316 INN or Proposed INN: ... | Marinus Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 50 | Phase 3 | United States;France;Hungary;Poland;Spain;Australia;Netherlands;Italy;United Kingdom | ||
| 4 | EUCTR2018-004496-12-NL (EUCTR) | 23/09/2019 | 05/06/2019 | A clinical study with an investigational drug called ganaxolone in female children with protocadherin 19 (PCDH19)-related epilepsy A clinical study with an investigational drug called ganaxolonein female children with protocadherin ... | A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female children with protocadherin 19 (PCDH19)-related epilepsy followed by long-term open-label treatment A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolonetreatment in female chi ... | protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032061;Term: Other forms of epilepsy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ... | Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT3162 INN or Proposed INN: GANAXOLONE Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT3162 INN or Proposed INN ... | Marinus Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 30 | Phase 2 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Belgium;Poland;Australia;Denmark;Netherlands;Germany United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Belgium;Poland;Australia;Denm ... | ||
| 5 | EUCTR2018-004496-12-IT (EUCTR) | 26/06/2019 | 20/01/2021 | A clinical study with an investigational drug called ganaxolone in female children with protocadherin 19 (PCDH19)-related epilepsy A clinical study with an investigational drug called ganaxolonein female children with protocadherin ... | A double-blind, randomized, placebo-controlled trial of adjunctiveganaxolone treatment in female children with protocadherin 19 (PCDH19)- related epilepsy followed by long-term open-label treatment - N/A A double-blind, randomized, placebo-controlled trial of adjunctiveganaxolone treatment in female chi ... | protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032062;Term: Other forms of epilepsy, with intractable epilepsy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ... | Product Name: Ganaxolone Product Code: [CCD 1042, MD 9150000, Mepalon 1042, SPT316] INN or Proposed INN: GANAXOLONE Product Name: Ganaxolone Product Code: [CCD 1042, MD 9150000, Mepalon 1042, SPT316] INN or Proposed IN ... | Marinus Pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 70 | Phase 3 | United States;Czechia;Israel;Italy;United Kingdom;France;Hungary;Belgium;Poland;Australia;Denmark;Germany;Netherlands United States;Czechia;Israel;Italy;United Kingdom;France;Hungary;Belgium;Poland;Australia;Denmark;Ge ... | ||
| 6 | NCT03865732 (ClinicalTrials.gov) | May 17, 2019 | 5/3/2019 | Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study) Study of Adjunctive GanaxoloneTreatment in Female Children With Protocadherin 19 (PCDH19)-Related Ep ... | A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy Followed by Long-term Open-label Treatment. A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive GanaxoloneTreatment in Female Chi ... | PCDH19-Related Epilepsy | Drug: Ganaxolone;Drug: Placebo | Marinus Pharmaceuticals | NULL | Active, not recruiting | 1 Year | 17 Years | Female | 25 | Phase 2 | United States;Hungary;Italy;Netherlands;Poland;Australia;France |
| 7 | EUCTR2015-001324-36-IT (EUCTR) | 05/06/2015 | 16/04/2015 | Pilot, multicenter study to evaluate the efficacy of the ganaxolone in female children with PCDH19 Pediatric Epilepsy. Pilot, multicenter study to evaluate the efficacy of the ganaxolonein female children with PCDH19 Pe ... | A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolone in Children with PCDH19 Female Pediatric Epilepsy A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolonein Children with PCDH19 Female Pediatr ... | PCDH19 Female Pediatric Epilepsy (FPE) MedDRA version: 18.0;Level: LLT;Classification code 10032062;Term: Other forms of epilepsy, with intractable epilepsy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] PCDH19 Female Pediatric Epilepsy (FPE) MedDRA version: 18.0;Level: LLT;Classification code 10032062; ... | Product Name: ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT316 INN or Proposed INN: GANAXOLONE Other descriptive name: Ganaxolone, SPT3162, MD 9150000, CCD-1042, Mepalon 1042, (3a-hydroxy-3ß-methyl-5a-pregnan-20-one) Product Name: ganaxolone Product Code: CCD 1042 INN or Proposed INN: GANAXOLONE Other descriptive name: Ganaxolone, SPT3162, MD 9150000, CCD-1042, Mepalon 1042, (3a-hydroxy-3ß-methyl-5a-pregnan-20-one) Product Name: ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT316 INN or Proposed INN: ... | Marinus Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 10 | United States;Italy | |||
| 8 | NCT02358538 (ClinicalTrials.gov) | March 2015 | 30/1/2015 | A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolonein Children With PCDH19 Female Pediatr ... | A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies Followed by 52 Week Open-Label Treatment A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolonein Children With PCDH19 Female Pediatr ... | Epilepsy | Drug: Ganaxolone | Marinus Pharmaceuticals | NULL | Active, not recruiting | 2 Years | 18 Years | All | 30 | Phase 2 | United States;Italy |
| 9 | EUCTR2018-004496-12-DK (EUCTR) | 07/11/2019 | A clinical study with an investigational drug called ganaxolone in female children with protocadherin 19 (PCDH19)-related epilepsy A clinical study with an investigational drug called ganaxolonein female children with protocadherin ... | A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female children with protocadherin 19 (PCDH19)-related epilepsy followed by long-term open-label treatment A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolonetreatment in female chi ... | protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032061;Term: Other forms of epilepsy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ... | Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT316 INN or Proposed INN: GANAXOLONE Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT316 INN or Proposed INN: ... | Marinus Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: no | 70 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Australia;Germany;Netherlands United States;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark ... | |||
| 10 | EUCTR2018-004496-12-PL (EUCTR) | 01/08/2019 | A clinical study with an investigational drug called ganaxolone in female children with protocadherin 19 (PCDH19)-related epilepsy A clinical study with an investigational drug called ganaxolonein female children with protocadherin ... | A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female children with protocadherin 19 (PCDH19)-related epilepsy followed by long-term open-label treatment A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolonetreatment in female chi ... | protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032061;Term: Other forms of epilepsy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ... | Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT3162 INN or Proposed INN: GANAXOLONE Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT3162 INN or Proposed INN ... | Marinus Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: no | 30 | Phase 2 | United States;Czechia;Spain;Ireland;Italy;United Kingdom;France;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands United States;Czechia;Spain;Ireland;Italy;United Kingdom;France;Hungary;Poland;Belgium;Australia;Den ... |
158. 結節性硬化症
臨床試験数 : 112 / 薬物数 : 71 - (DrugBank : 19) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 118
Showing 1 to 3 of 3 diseases
| 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 | NCT05604170 (ClinicalTrials.gov) | May 16, 2022 | 5/10/2022 | Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy | A Phase 3, Open-label Study of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults With Tuberous Sclerosis Complex (TSC)-Related Epilepsy (TrustTSC OLE) A Phase 3, Open-label Study of Adjunctive Ganaxolone(GNX) Treatment in Children and Adults With Tube ... | Tuberous Sclerosis Complex | Drug: Ganaxolone | Marinus Pharmaceuticals | NULL | Enrolling by invitation | 1 Year | 65 Years | All | 169 | Phase 3 | United States |
| 2 | NCT05323734 (ClinicalTrials.gov) | April 1, 2022 | 21/3/2022 | Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy | A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults With Tuberous Sclerosis Complex (TSC)-Related Epilepsy (TrustTSC) A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone(GNX) Treatmen ... | Tuberous Sclerosis Complex | Drug: Ganaxalone;Drug: Placebo | Marinus Pharmaceuticals | NULL | Recruiting | 1 Year | 65 Years | All | 162 | Phase 3 | United States;Canada;France;Germany;Israel;Italy;Spain;United Kingdom |
| 3 | NCT04285346 (ClinicalTrials.gov) | April 8, 2020 | 18/2/2020 | Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B) | A Phase 2 Open-label 12-Week Trial of Adjunctive Ganaxolone Treatment (Part A) in Tuberous Sclerosis Complex-related Epilepsy Followed by Long-term Treatment (Part B) A Phase 2 Open-label 12-Week Trial of Adjunctive GanaxoloneTreatment (Part A) in Tuberous Sclerosis ... | Tuberous Sclerosis | Drug: Ganaxolone | Marinus Pharmaceuticals | NULL | Completed | 2 Years | 65 Years | All | 24 | Phase 2 | United States |
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
Showing 1 to 2 of 2 diseases
| 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 | EUCTR2014-000251-89-BE (EUCTR) | 22/10/2014 | 18/08/2014 | A clinical study with an investigational drug called ganaxolone in children with fragile X syndrome | A controlled double-blind crossover trial of ganaxolone in children with fragile X syndrome - GNX study A controlled double-blind crossover trial of ganaxolonein children with fragile X syndrome - GNX stu ... | behavioral problems in children with fragile X syndrome MedDRA version: 17.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] behavioral problems in children with fragile X syndrome MedDRA version: 17.0;Level: PT;Classificatio ... | Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT316 INN or Proposed INN: GANAXOLONE Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT316 INN or Proposed INN: ... | Antwerp University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 60 | United States;Belgium | |||
| 2 | NCT01725152 (ClinicalTrials.gov) | November 2012 | 7/11/2012 | Ganaxolone Treatment in Children With Fragile X Syndrome | A Controlled, Double-blind, Crossover Trial of Ganaxolone in Children With Fragile X Syndrome | Fragile x Syndrome | Drug: Ganaxolone;Drug: Placebo | Marinus Pharmaceuticals | University of California, Davis;U.S. Army Medical Research and Development Command | Completed | 6 Years | 17 Years | All | 59 | Phase 2 | United States;Belgium |