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 | 3 |
| 114 | 非ジストロフィー性ミオトニー症候群 | 6 |
| 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 mexiletine hydrochroride in spinal and bulbar muscular atrophy (SBMA) :a multicenter, randomised, double-blind, placebo-controlled trial | 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 |
| 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 Mexiletine in Patients With Sporadic Amyotrophic Lateral Sclerosis (SALS) | 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 | 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 |
| 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 |
| 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) | November 16, 2020 | 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 Efficacy of Mexiletine in Adolescents and Children With Myotonic Disorders | Myotonic Dystrophy | Drug: Mexiletine | Lupin Ltd. | NULL | Not yet recruiting | 6 Years | 18 Years | All | 14 | Phase 3 | NULL |
| 2 | NCT04616807 (ClinicalTrials.gov) | October 31, 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 Symptomatic Management of Myotonia in Adult Patients With Non-dystrophic Myotonic Disorders | Myotonic Dystrophy | Drug: Mexiletine | Lupin Ltd. | NULL | Not yet recruiting | 18 Years | N/A | All | 50 | NULL | |
| 3 | 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 Mexiletine for Myotonic Dystrophy Type-1 (DM1) | Myotonic Dystrophy | Drug: Mexiletine;Drug: Placebo | University of Rochester | NULL | Completed | 18 Years | 80 Years | All | 42 | Phase 2 | United States |
| 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 | EUCTR2014-002627-10-IT (EUCTR) | 03/11/2015 | 05/11/2020 | Pivotal 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 BESTA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 58 | Phase 2 | Italy | ||
| 2 | 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 Bayesian Hierarchical Modeling. The Case of Mexiletine for Patients With Non- Dystrophic Myotonia. | 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 |
| 3 | 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 hierarchical modeling. The case of Mexilitin for patients with Non-Dystrophic Myotonia. - Mex vs. placebo in NDMs | Combining 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 Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Netherlands | |||
| 4 | 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 |
| 5 | 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 (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 Center | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United Kingdom;Italy | ||
| 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 |
| 6 | 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 |