LAMOTRIGINE ( DrugBank: Lamotrigine )


5 diseases
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica3
34Neurofibromatosis5
38Stevens-Johnson syndrome1
114Non-dystrophic myotonia syndrome5
144Lennox-Gastaut syndrome1

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,340 Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00917839
(ClinicalTrials.gov)
June 20099/6/2009The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple SclerosisRandomized, 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 SclerosisDrug: lamotrigineCantonal Hospital of St. GallenNULLRecruiting18 Years50 YearsBoth88Phase 2Switzerland
2NCT00257855
(ClinicalTrials.gov)
November 200522/11/2005A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple SclerosisA Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis: Single Centre, Phase 2 TrialSecondary Progressive Multiple SclerosisDrug: LamotrigineUniversity College London HospitalsNULLCompleted18 Years60 YearsBoth120Phase 2United Kingdom
3EUCTR2005-001949-42-GB
(EUCTR)
08/09/200504/07/2005A randomised controlled trial of neuroprotection with lamotrigine in secondary progressive multiple sclerosis - Neuroprotection with lamotrigine in multiple sclerosisA randomised controlled trial of neuroprotection with lamotrigine in secondary progressive multiple sclerosis - Neuroprotection with lamotrigine in multiple sclerosis Multiple sclerosisProduct Name: Lamotrigine extended release tablets
Product Code: N/A
INN or Proposed INN: Lamotrigine
Other descriptive name: N/A
University College LondonNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom

34. Neurofibromatosis


Clinical trials : 133 Drugs : 186 - (DrugBank : 67) / Drug target genes : 79 - Drug target pathways : 190
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-003405-26-DK
(EUCTR)
22/02/201824/04/2017Treating learning disabilities in Neurofibromatosis 1 using lamotrigineThe 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 MCNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Spain;Belgium;Denmark;Netherlands
2EUCTR2013-003405-26-ES
(EUCTR)
16/10/201731/07/2017Treating learning disabilities in Neurofibromatosis 1 using lamotrigineThe 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 MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Belgium;Spain;Netherlands
3EUCTR2013-003405-26-BE
(EUCTR)
30/04/201530/03/2015Treating learning disabilities in Neurofibromatosis 1 using lamotrigineThe 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 dispersErasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Belgium;Netherlands
4NCT02256124
(ClinicalTrials.gov)
October 201417/9/2014Effect of Lamotrigine on Cognition in NF1The Effect of Lamotrigine on Cognitive Deficits Associated With Neurofibromatosis Type 1: a Phase II Randomized Controlled Multi-centre Trial (NF1-EXCEL)Neurofibromatosis Type 1Drug: Lamotrigine;Drug: PlaceboErasmus Medical CenterUniversitaire Ziekenhuizen Leuven;ZonMw: The Netherlands Organisation for Health Research and Development;Hospital Sant Joan de DeuTerminated12 Years18 YearsAll41Phase 2/Phase 3Belgium;Netherlands;Spain
5EUCTR2013-003405-26-NL
(EUCTR)
03/09/201420/09/2013Treating learning disabilities in Neurofibromatosis 1 using lamotrigineThe 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 MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Netherlands

38. Stevens-Johnson syndrome


Clinical trials : 17 Drugs : 29 - (DrugBank : 9) / Drug target genes : 15 - Drug target pathways : 101
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-003136-23-GB
(EUCTR)
27/11/201216/11/2012Lamotrigine And Borderline Personality Disorder: Investigating Long-Term EffectivenessLamotrigine 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]
Trade Name: Lamotrigine - generic product
Product Name: Lamotrigine
Product Code: n/a
INN or Proposed INN: Lamotrigine
Other descriptive name: 6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine
Imperial College LondonNULLNot Recruiting Female: yes
Male: yes
252 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom

114. Non-dystrophic myotonia syndrome


Clinical trials : 13 Drugs : 19 - (DrugBank : 5) / Drug target genes : 18 - Drug target pathways : 10
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05639257
(ClinicalTrials.gov)
December 5, 20224/10/2022Treatment of Myotonia - Lamotrigine Versus NamusclaTreatment of Myotonia - Lamotrigine Versus NamusclaNon-Dystrophic MyotoniaDrug: Lamotrigine;Drug: NamusclaGrete Andersen, MDGCP-Copenhagen;Region Capital Denmark;Danish Region;Lupin Atlantis Holdings S.A.;ZiteLabRecruiting18 YearsN/AAll32N/ADenmark
2EUCTR2021-003784-94-DK
(EUCTR)
20/01/202230/11/2021Which treatment are the best to reduce myotonia?Treatment of Myotonia - Lamotrigine versus Namuscla Myotonia Congenita (Becker and Thomsen type), Paramyotonia Congenita, and Hyperkalemic periodic paralysis
MedDRA version: 20.1;Level: LLT;Classification code 10049841;Term: Myotonia congenital;System Organ Class: 100000004850
MedDRA version: 20.1;Classification code 10076440;Term: Hyperkalemic periodic paralysis;System Organ Class: 100000004850;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: Namuscla
INN or Proposed INN: Mexiletine
Trade Name: Lamotrigin ”Nordic Prime 25 mg
INN or Proposed INN: LAMOTRIGINE
Trade Name: Lamotrigin ”Nordic Prime 50 mg
INN or Proposed INN: LAMOTRIGINE
Trade Name: Lamotrigin ”Nordic Prime 100 mg
INN or Proposed INN: LAMOTRIGINE
Rigshospitalet, department of NeurologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 3Denmark
3NCT05017155
(ClinicalTrials.gov)
August 12, 202111/8/2021MExiletine Versus Lamotrigine in Non-Dystrophic MyotoniasA Phase III, Randomised, Double Blinded, Head-to-head, Single-site, Cross-over Trial of Lamotrigine Versus Mexiletine for Non-dystrophic MyotoniasNon-Dystrophic MyotoniaDrug: Mexiletine;Drug: Lamotrigine 25Mg Oral Tablet, Extended ReleaseUniversity College, LondonNULLRecruiting18 Years90 YearsAll60Phase 3United Kingdom
4NCT01939561
(ClinicalTrials.gov)
November 201323/8/2013Lamotrigine as Treatment of MyotoniaLamotrigine as Treatment of Myotonia - a Phase 3 Randomized Controlled Trial StudyDystrophia Myotonica Type 1;Myotonia Congenita;Paramyotonia Congenita;Hyperkalemic Periodic Paralysis;Potassium-Aggravated MyotoniaDrug: Lamotrigine;Drug: PlaceboGrete Andersen, MDNULLCompleted18 YearsN/ABoth27Phase 3Denmark
5EUCTR2013-003309-24-DK
(EUCTR)
28/10/201321/10/2013Better treatment of muscle diseasesLamotrigine 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 AndersenNULLNot RecruitingFemale: yes
Male: yes
Denmark

144. Lennox-Gastaut syndrome


Clinical trials : 111 Drugs : 72 - (DrugBank : 14) / Drug target genes : 49 - Drug target pathways : 61
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-023505-36-IT
(EUCTR)
29/09/201105/01/2012A 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 SyndromeA 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 UKNULLNot RecruitingFemale: yes
Male: yes
75Greece;Italy