Mexiletine ( DrugBank: Mexiletine )


5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
1球脊髄性筋萎縮症1
2筋萎縮性側索硬化症4
10シャルコー・マリー・トゥース病1
113筋ジストロフィー4
114非ジストロフィー性ミオトニー症候群8

1. 球脊髄性筋萎縮症


臨床試験数 : 17 薬物数 : 16 - (DrugBank : 8) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 17
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000026150
2017/04/2531/03/2017Safety and efficacy of mexiletine hydrochroride in spinal and bulbar muscular atrophy (SBMA) :a multicenter, randomised, double-blind, placebo-controlled trial Spinal and Bulbar Muscular AtrophyMexiletine Hydrochloride 300mg daily, for 4 weeks
placebo for 4 weeks
Nagoya University Graduate School of MedicineNULLComplete: follow-up continuing20years-old80years-oldMale20Phase 2Japan

2. 筋萎縮性側索硬化症


臨床試験数 : 624 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02781454
(ClinicalTrials.gov)
October 201610/5/2016Mexiletine in Sporadic Amyotrophic Lateral SclerosisEffect of Mexiletine on Cortical Hyperexcitability in Sporadic Amyotrophic Lateral Sclerosis (SALS)Sporadic Amyotrophic Lateral SclerosisDrug: Mexiletine;Drug: PlaceboUniversity of WashingtonMassachusetts General HospitalCompleted18 YearsN/AAll20Phase 2United States
2NCT01849770
(ClinicalTrials.gov)
July 20136/5/2013Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS)A Safety and Tolerability Study of Mexiletine in Patients With Sporadic Amyotrophic Lateral Sclerosis (SALS)Sporadic Amyotrophic Lateral SclerosisDrug: Mexiletine;Drug: PlaceboUniversity of WashingtonNULLCompleted18 YearsN/AAll75Phase 2United States
3NCT01811355
(ClinicalTrials.gov)
May 20136/3/2013Mexiletine for the Treatment of Muscle Cramps in ALSMexiletine for the Treatment of Muscle Cramps in ALSMuscle Cramps in Amyotrophic Lateral SclerosisDrug: Mexiletine;Drug: PlaceboBjorn Oskarsson, MDUniversity of California, Davis;ALS AssociationCompleted21 Years89 YearsAll23Phase 4United States
4JPRN-UMIN000006423
2011/10/0101/10/2011The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis amyotrophic lateral sclerosisadministration of mexiletine and riluzole
administration of riluzole only
Department of Neurology, Graduate School of Medicine, Chiba University, Japan.NULLComplete: follow-up complete20years-oldNot applicableMale and Female60Not selectedJapan

10. シャルコー・マリー・トゥース病


臨床試験数 : 39 薬物数 : 44 - (DrugBank : 9) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 15
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02561702
(ClinicalTrials.gov)
September 201524/9/2015Mexiletine for Muscle Cramps in Charcot Marie Tooth DiseaseMexiletine for Muscle Cramps in Charcot Marie Tooth DiseaseCharcot Marie Tooth DiseaseOther: Placebo;Drug: MexiletineUniversity of RochesterNULLCompleted18 YearsN/AAll4Phase 2United States

113. 筋ジストロフィー


臨床試験数 : 622 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04624750
(ClinicalTrials.gov)
September 3, 202120/10/2020Open Label Study in Adolescents and Children With Myotonic DisordersAn Open-label, Non-Comparative Study to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of Mexiletine in Adolescents and Children With Myotonic DisordersMyotonic DystrophyDrug: MexiletineLupin Ltd.NULLRecruiting6 Years18 YearsAll14Phase 3France
2NCT04700046
(ClinicalTrials.gov)
July 6, 20215/1/2021Study to Investigate the Efficacy and Safety of Mexiletine in Patients With Myotonic Dystrophy Type 1 and Type 2A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of Mexiletine During 26 Weeks of Treatment in Patients With Myotonic Dystrophy Type 1 and Type 2 [The MIND Study]Myotonic Dystrophy Type 1 and Type 2Drug: Mexiletine 167 mg;Drug: PlaceboLupin Ltd.NULLNot yet recruiting18 YearsN/AAll158Phase 3NULL
3NCT04616807
(ClinicalTrials.gov)
December 17, 202023/10/2020An Observational Study in Adult Patients With Non-dystrophic Myotonic DisordersAn Observational Study to Describe the Long-term Safety and Effectiveness of Namuscla in the Symptomatic Management of Myotonia in Adult Patients With Non-dystrophic Myotonic DisordersMyotonic DystrophyDrug: MexiletineLupin Ltd.NULLRecruiting18 YearsN/AAll50France;Germany;United Kingdom
4NCT01406873
(ClinicalTrials.gov)
June 201120/7/2011Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1A Randomized, Placebo Controlled, Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type-1 (DM1)Myotonic DystrophyDrug: Mexiletine;Drug: PlaceboUniversity of RochesterNULLCompleted18 Years80 YearsAll42Phase 2United States

114. 非ジストロフィー性ミオトニー症候群


臨床試験数 : 12 薬物数 : 19 - (DrugBank : 5) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 10
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-003784-94-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
2NCT05017155
(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
3EUCTR2014-002627-10-IT
(EUCTR)
03/11/201505/11/2020Pivotal study to evaluate the efficacy and safety of riluzole versus mexiletine in patients with non dystrophic myotonia mutated in SCN4A orCLCN1 genes.A randomized, double-blind, controlled, monocenter, pivotal phase IIb study to evaluate the efficacy and safety of riluzole versus mexiletine in patients with non dystrophic myotonia mutated in SCN4A or CLCN1 genes. - RILUMEX NDM patients with mutations in SCN4A or CLCN1 gene
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: RILUZOLO TEVA - 50 MG COMPRESSE RIVESTITE CON FILM 90 COMPRESSE IN BLISTER AL/PVC
Product Name: RILUZOLO
INN or Proposed INN: RILUZOLO
INN or Proposed INN: MEXILETINA CLORIDRATO
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
58Phase 2Italy
4NCT02045667
(ClinicalTrials.gov)
January 201418/11/2013Combined N-of-1 Trials Mexiletine vs Placebo in Patients With Non-Dystrophic Myotonia (NDM)Combining N-of-1 Trials to Estimate Population Clinical and Cost-effectiveness of Drugs Using Bayesian Hierarchical Modeling. The Case of Mexiletine for Patients With Non- Dystrophic Myotonia.Non Dystrophic MyotoniaDrug: Mexiletine;Drug: PlaceboRadboud UniversityZonMw: The Netherlands Organisation for Health Research and DevelopmentCompleted18 YearsN/ABoth30Phase 2Netherlands
5EUCTR2010-024026-38-NL
(EUCTR)
10/01/201209/02/2011Combining N-of-1 trials to estimate population clinical effectiveness of drugs using Bayesian hierarchical modeling. The case of Mexilitin for patients with Non-Dystrophic Myotonia. - Mex vs. placebo in NDMsCombining N-of-1 trials to estimate population clinical effectiveness of drugs using Bayesian hierarchical modeling. The case of Mexilitin for patients with Non-Dystrophic Myotonia. - Mex vs. placebo in NDMs Patients with non-dystrophic myotonic syndromes (NDMs). NDMs are caused by mutations in the gene encoding for the skeletal muscle sodium (SCN4A) or chloride (CLCN1) channel. In this study patients with NDMs with a genetically confirmed mutation in the SCN4A-gene or the CLCN1-gene as registred in the Netherlands database of NDMs will be included. Trade Name: Mexitil
Product Name: mexitil
INN or Proposed INN: MEXILETINE
Other descriptive name: Mexitil
Radboud University Nijmegen Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Netherlands
6NCT02336477
(ClinicalTrials.gov)
June 20118/1/2015Mexiletine and Non Dystrophic MyotoniasEfficacy and Safety of Mexiletine in Non-dystrophic MyotoniasNon-dystrophic Myotonias;Paramyotonia Congenita;Myotonia CongenitaDrug: Mexiletine;Drug: placeboAssistance Publique - Hôpitaux de ParisNULLCompleted18 Years65 YearsBoth24Phase 3France
7EUCTR2009-011184-36-IT
(EUCTR)
25/06/201005/09/2011Phase II Therapeutic Trial of Mexiletine in Non-Dystrophic Myotonia (IND #77,021) - NDPhase II Therapeutic Trial of Mexiletine in Non-Dystrophic Myotonia (IND #77,021) - ND Myotonic disorders are divided into dystrophic myotonias (DM1 and DM2) and non-dystrophic myotonias (NDM). The dystrophic myotonias are associated with significant progressive muscular weakness and other systemic organ involvement. On the other hand, NDM usually presents with muscle stiffness as the primary symptom, and severe weakness is not considered a major feature, especially in myotonia congenita.
MedDRA version: 14.0;Level: LLT;Classification code 10032487;Term: Other specific muscle disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MEXITIL*20CPS 200MG
INN or Proposed INN: Mexiletine
Dept. of Neurology - Univ. of Kansas Medical CenterNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United Kingdom;Italy
8NCT00832000
(ClinicalTrials.gov)
December 200827/1/2009Effectiveness of Mexiletine for Treating People With Non-Dystrophic MyotoniaPhase II Therapeutic Trial of Mexiletine in Non-Dystrophic MyotoniaMyotonia;Non-Dystrophic MyotoniaDrug: Mexiletine;Drug: PlaceboRichard Barohn, MDNULLCompleted16 YearsN/AAll59Phase 2United States;Canada;Italy;United Kingdom