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 : 18 / 薬物数 : 15 - (DrugBank : 8) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 17

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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	JPRN-UMIN000026150	2017/04/25	31/03/2017	Safety and efficacy of mexiletinehydrochroride in spinal and bulbar muscular atrophy (SBMA) :a multi ...	Safety and efficacy of mexiletinehydrochroride in spinal and bulbar muscular atrophy (SBMA) :a multi ...	Spinal and Bulbar Muscular Atrophy	Mexiletine Hydrochloride 300mg daily, for 4 weeks placebo for 4 weeks	Nagoya University Graduate School of Medicine	NULL	Complete: follow-up continuing	20years-old	80years-old	Male	20	Phase 2	Japan

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2. 筋萎縮性側索硬化症

臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225

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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	NCT02781454 (ClinicalTrials.gov)	October 2016	10/5/2016	Mexiletine in Sporadic Amyotrophic Lateral Sclerosis	Effect of Mexiletine on Cortical Hyperexcitability in Sporadic Amyotrophic Lateral Sclerosis (SALS)	Sporadic Amyotrophic Lateral Sclerosis	Drug: Mexiletine;Drug: Placebo	University of Washington	Massachusetts General Hospital	Completed	18 Years	N/A	All	20	Phase 2	United States
2	NCT01849770 (ClinicalTrials.gov)	July 2013	6/5/2013	Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS)	A Safety and Tolerability Study of Mexiletinein Patients With Sporadic Amyotrophic Lateral Sclerosis ...	Sporadic Amyotrophic Lateral Sclerosis	Drug: Mexiletine;Drug: Placebo	University of Washington	NULL	Completed	18 Years	N/A	All	75	Phase 2	United States
3	NCT01811355 (ClinicalTrials.gov)	May 2013	6/3/2013	Mexiletine for the Treatment of Muscle Cramps in ALS	Mexiletine for the Treatment of Muscle Cramps in ALS	Muscle Cramps in Amyotrophic Lateral Sclerosis	Drug: Mexiletine;Drug: Placebo	Bjorn Oskarsson, MD	University of California, Davis;ALS Association	Completed	21 Years	89 Years	All	23	Phase 4	United States
4	JPRN-UMIN000006423	2011/10/01	01/10/2011	The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis	The clinical trial to assess efficacy of mexiletinefor amyotrophic lateral sclerosis - Mexiletineon ...	amyotrophic lateral sclerosis	administration of mexiletine and riluzole administration of riluzole only	Department of Neurology, Graduate School of Medicine, Chiba University, Japan.	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	60	Not selected	Japan

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10. シャルコー・マリー・トゥース病

臨床試験数 : 41 / 薬物数 : 46 - (DrugBank : 9) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 15

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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	NCT02561702 (ClinicalTrials.gov)	September 2015	24/9/2015	Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease	Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease	Charcot Marie Tooth Disease	Other: Placebo;Drug: Mexiletine	University of Rochester	NULL	Completed	18 Years	N/A	All	4	Phase 2	United States

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113. 筋ジストロフィー

臨床試験数 : 646 / 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170

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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	NCT04624750 (ClinicalTrials.gov)	September 3, 2021	20/10/2020	Open Label Study in Adolescents and Children With Myotonic Disorders	An Open-label, Non-Comparative Study to Evaluate the Steady-State Pharmacokinetics, Safety, and Effi ...	Myotonic Dystrophy	Drug: Mexiletine	Lupin Ltd.	NULL	Recruiting	6 Years	18 Years	All	14	Phase 3	France
2	NCT04700046 (ClinicalTrials.gov)	July 6, 2021	5/1/2021	Study to Investigate the Efficacy and Safety of Mexiletinein Patients With Myotonic Dystrophy Type 1 ...	A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Investigate the Efficacy and S ...	Myotonic Dystrophy Type 1 and Type 2	Drug: Mexiletine 167 mg;Drug: Placebo	Lupin Ltd.	NULL	Not yet recruiting	18 Years	N/A	All	158	Phase 3	NULL
3	NCT04616807 (ClinicalTrials.gov)	December 17, 2020	23/10/2020	An Observational Study in Adult Patients With Non-dystrophic Myotonic Disorders	An Observational Study to Describe the Long-term Safety and Effectiveness of Namuscla in the Symptom ...	Myotonic Dystrophy	Drug: Mexiletine	Lupin Ltd.	NULL	Active, not recruiting	18 Years	N/A	All	53		France;Germany;United Kingdom
4	NCT01406873 (ClinicalTrials.gov)	June 2011	20/7/2011	Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1	A Randomized, Placebo Controlled, Clinical Efficacy Trial of Mexiletinefor Myotonic Dystrophy Type-1 ...	Myotonic Dystrophy	Drug: Mexiletine;Drug: Placebo	University of Rochester	NULL	Completed	18 Years	80 Years	All	42	Phase 2	United States

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114. 非ジストロフィー性ミオトニー症候群

臨床試験数 : 13 / 薬物数 : 19 - (DrugBank : 5) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 10

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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	EUCTR2021-003784-94-DK (EUCTR)	20/01/2022	30/11/2021	Which treatment are the best to reduce myotonia?	Treatment of Myotonia - Lamotrigine versus Namuscla	Myotonia Congenita (Becker and Thomsen type), Paramyotonia Congenita, and Hyperkalemic periodic para ...	Trade Name: Namuscla INN or Proposed INN: Mexiletine Trade Name: Lamotrigin ”Nordic Prime 25 mg INN or ...	Rigshospitalet, department of Neurology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	32	Phase 3	Denmark
2	NCT05017155 (ClinicalTrials.gov)	August 12, 2021	11/8/2021	MExiletine Versus Lamotrigine in Non-Dystrophic Myotonias	A Phase III, Randomised, Double Blinded, Head-to-head, Single-site, Cross-over Trial of Lamotrigine ...	Non-Dystrophic Myotonia	Drug: Mexiletine;Drug: Lamotrigine 25Mg Oral Tablet, Extended Release	University College, London	NULL	Recruiting	18 Years	90 Years	All	60	Phase 3	United Kingdom
3	EUCTR2014-002627-10-IT (EUCTR)	03/11/2015	05/11/2020	Pivotal study to evaluate the efficacy and safety of riluzole versus mexiletinein patients with non ...	A randomized, double-blind, controlled, monocenter, pivotal phase IIb study to evaluate the efficacy ...	NDM patients with mutations in SCN4A or CLCN1 gene MedDRA version: 20.0;Level: SOC;Classification co ...	Trade Name: RILUZOLO TEVA - 50 MG COMPRESSE RIVESTITE CON FILM 90 COMPRESSE IN BLISTER AL/PVC Product ...	FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	58	Phase 2	Italy
4	NCT02045667 (ClinicalTrials.gov)	January 2014	18/11/2013	Combined 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 Bayesi ...	Non Dystrophic Myotonia	Drug: Mexiletine;Drug: Placebo	Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development	Completed	18 Years	N/A	Both	30	Phase 2	Netherlands
5	EUCTR2010-024026-38-NL (EUCTR)	10/01/2012	09/02/2011	Combining N-of-1 trials to estimate population clinical effectiveness of drugs using Bayesian hierar ...	Combining N-of-1 trials to estimate population clinical effectiveness of drugs using Bayesian hierar ...	Patients with non-dystrophic myotonic syndromes (NDMs). NDMs are caused by mutations in the gene enc ...	Trade Name: Mexitil Product Name: mexitil INN or Proposed INN: MEXILETINE Other descriptive name: Mexit ...	Radboud University Nijmegen Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30		Netherlands
6	NCT02336477 (ClinicalTrials.gov)	June 2011	8/1/2015	Mexiletine and Non Dystrophic Myotonias	Efficacy and Safety of Mexiletine in Non-dystrophic Myotonias	Non-dystrophic Myotonias;Paramyotonia Congenita;Myotonia Congenita	Drug: Mexiletine;Drug: placebo	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	65 Years	Both	24	Phase 3	France
7	EUCTR2009-011184-36-IT (EUCTR)	25/06/2010	05/09/2011	Phase II Therapeutic Trial of Mexiletine in Non-Dystrophic Myotonia (IND #77,021) - ND	Phase 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 ...	Trade Name: MEXITIL*20CPS 200MG INN or Proposed INN: Mexiletine	Dept. of Neurology - Univ. of Kansas Medical Center	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United Kingdom;Italy
8	NCT00832000 (ClinicalTrials.gov)	December 2008	27/1/2009	Effectiveness of Mexiletine for Treating People With Non-Dystrophic Myotonia	Phase II Therapeutic Trial of Mexiletine in Non-Dystrophic Myotonia	Myotonia;Non-Dystrophic Myotonia	Drug: Mexiletine;Drug: Placebo	Richard Barohn, MD	NULL	Completed	16 Years	N/A	All	59	Phase 2	United States;Canada;Italy;United Kingdom

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