Lamotrigine (DrugBank: Lamotrigine)
5 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 3 |
| 34 | 神経線維腫症 | 5 |
| 38 | スティーヴンス・ジョンソン症候群 | 1 |
| 114 | 非ジストロフィー性ミオトニー症候群 | 2 |
| 144 | レノックス・ガストー症候群 | 1 |
| 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 | NCT00917839 (ClinicalTrials.gov) | June 2009 | 9/6/2009 | The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis | Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis. | Relapsing-Remitting Multiple Sclerosis | Drug: lamotrigine | Cantonal Hospital of St. Gallen | NULL | Recruiting | 18 Years | 50 Years | Both | 88 | Phase 2 | Switzerland |
| 2 | NCT00257855 (ClinicalTrials.gov) | November 2005 | 22/11/2005 | A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis | A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis: Single Centre, Phase 2 Trial | Secondary Progressive Multiple Sclerosis | Drug: Lamotrigine | University College London Hospitals | NULL | Completed | 18 Years | 60 Years | Both | 120 | Phase 2 | United Kingdom |
| 3 | EUCTR2005-001949-42-GB (EUCTR) | 08/09/2005 | 04/07/2005 | A randomised controlled trial of neuroprotection with lamotrigine in secondary progressive multiple sclerosis - Neuroprotection with lamotrigine in multiple sclerosis | A randomised controlled trial of neuroprotection with lamotrigine in secondary progressive multiple sclerosis - Neuroprotection with lamotrigine in multiple sclerosis | Multiple sclerosis | University College London | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United Kingdom |
| 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 | EUCTR2013-003405-26-DK (EUCTR) | 22/02/2018 | 24/04/2017 | Treating learning disabilities in Neurofibromatosis 1 using lamotrigine | The effect of Lamotrigine on cognitive deficits associated with Neurofibromatosis type 1: a phase II randomized controlled multi-centre trial (NF1-EXCEL) - Treating learning disabilities in Neurofibromatosis 1 using lamotrigine | Neurofibromatosis type 1 MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Lamotrigine dispers INN or Proposed INN: Lamotrigine Other descriptive name: LAMOTRIGINE INN or Proposed INN: lamotrigine Other descriptive name: LAMOTRIGINE | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Spain;Belgium;Denmark;Netherlands | ||
| 2 | EUCTR2013-003405-26-ES (EUCTR) | 16/10/2017 | 31/07/2017 | Treating learning disabilities in Neurofibromatosis 1 using lamotrigine | The effect of Lamotrigine on cognitive deficits associated with Neurofibromatosis type 1: a phase II randomized controlled multi-centre trial (NF1-EXCEL) | Neurofibromatosis type 1 MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000012614;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Lamotrigine dispers INN or Proposed INN: Lamotrigine Other descriptive name: LAMOTRIGINE Trade Name: Lamotrigine dispers INN or Proposed INN: Lamotrigine Other descriptive name: LAMOTRIGINE Trade Name: Lamotrigine dispers INN or Proposed INN: Lamotrigine Other descriptive name: LAMOTRIGINE Trade Name: Lamotrigine dispers INN or Proposed INN: Lamotrigine Other descriptive name: LAMOTRIGINE Trade Name: Lamotrigine dispers INN or Proposed INN: Lamotrigine Other descriptive name: LAMOTRIGINE Trade Name: Lamotrigine dispers INN or Proposed INN: Lamotrigine Other descriptive name: LAMOTRIGINE | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Belgium;Spain;Netherlands | ||
| 3 | EUCTR2013-003405-26-BE (EUCTR) | 30/04/2015 | 30/03/2015 | Treating learning disabilities in Neurofibromatosis 1 using lamotrigine | The effect of Lamotrigine on cognitive deficits associated with Neurofibromatosis type 1: a phase II randomized controlled multi-centre trial (NF1-EXCEL) | Neurofibromatosis type 1 MedDRA version: 17.1;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Lamotrigine dispers | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Belgium;Netherlands | ||
| 4 | NCT02256124 (ClinicalTrials.gov) | October 2014 | 17/9/2014 | Effect of Lamotrigine on Cognition in NF1 | The Effect of Lamotrigine on Cognitive Deficits Associated With Neurofibromatosis Type 1: a Phase II Randomized Controlled Multi-centre Trial (NF1-EXCEL) | Neurofibromatosis Type 1 | Drug: Lamotrigine;Drug: Placebo | Erasmus Medical Center | Universitaire Ziekenhuizen Leuven;ZonMw: The Netherlands Organisation for Health Research and Development;Hospital Sant Joan de Deu | Terminated | 12 Years | 18 Years | All | 41 | Phase 2;Phase 3 | Belgium;Netherlands;Spain |
| 5 | EUCTR2013-003405-26-NL (EUCTR) | 03/09/2014 | 20/09/2013 | Treating learning disabilities in Neurofibromatosis 1 using lamotrigine | The effect of Lamotrigine on cognitive deficits associated with Neurofibromatosis type 1: a phase II randomized controlled multi-centre trial (NF1-EXCEL) | Neurofibromatosis type 1 MedDRA version: 17.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Lamotrigine dispers INN or Proposed INN: Lamotrigine Other descriptive name: LAMOTRIGINE INN or Proposed INN: lamotrigine Other descriptive name: LAMOTRIGINE | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Netherlands |
| 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 | EUCTR2012-003136-23-GB (EUCTR) | 27/11/2012 | 16/11/2012 | Lamotrigine And Borderline Personality Disorder: Investigating Long-Term Effectiveness | Lamotrigine And Borderline Personality Disorder: Investigating Long-Term Effectiveness - LABILE | Borderline Personality Disorder MedDRA version: 14.1;Level: PT;Classification code 10042033;Term: Stevens-Johnson syndrome;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Classification code 10019211;Term: Headache;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 15.0;Level: LLT;Classification code 10028821;Term: Nausea with vomiting;System Organ Class: 100000004856 MedDRA version: 14.1;Classification code 10040913;Term: Skin rash;Classification code 10024264;Term: Lethargy;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10013649;Term: Drowsiness;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03] | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 4 | United Kingdom |
| 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 | NCT01939561 (ClinicalTrials.gov) | November 2013 | 23/8/2013 | Lamotrigine as Treatment of Myotonia | Lamotrigine as Treatment of Myotonia - a Phase 3 Randomized Controlled Trial Study | Dystrophia Myotonica Type 1;Myotonia Congenita;Paramyotonia Congenita;Hyperkalemic Periodic Paralysis;Potassium-Aggravated Myotonia | Drug: Lamotrigine;Drug: Placebo | Grete Andersen, MD | NULL | Completed | 18 Years | N/A | Both | 27 | Phase 3 | Denmark |
| 2 | EUCTR2013-003309-24-DK (EUCTR) | 28/10/2013 | 21/10/2013 | Better treatment of muscle diseases | Lamotrigine as treatment of Myotonia | Myotonia is a symptom seen certain inherited muscle dystrophies and pure channelopathies (Dystrophia myotonica type 1 and 2, Myotonia Congenita, Paramyotonia Congenita, Hyperkalæmisk periodic paralysis and Potassium-Aggravated myotonia). Genetically, mutations in chloride, sodium or calcium ion channels in the muscle is present. Myotonia manifests during physical activity where the muscle can locks in the middle of a movement. Patients are limited in their physical as well as social activities. MedDRA version: 14.1;Level: PT;Classification code 10061533;Term: Myotonia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Lamotrigin actavis INN or Proposed INN: Lamotrigine Other descriptive name: LAMOTRIGINE | Grete Andersen | NULL | Not Recruiting | Female: yes Male: yes | Denmark |
| 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 | EUCTR2010-023505-36-IT (EUCTR) | 29/09/2011 | 05/01/2012 | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately Controlled Lennox-Gastaut Syndrome | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately Controlled Lennox-Gastaut Syndrome - E2080-G000-303 | Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Inovelon Other descriptive name: Rufinamide oral suspension INN or Proposed INN: lamotrigine Other descriptive name: Lamictal INN or Proposed INN: sodio valproato INN or Proposed INN: topimarato Other descriptive name: topimarate | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 75 | Greece;Italy |