114. 非ジストロフィー性ミオトニー症候群 Non-dystrophic myotonia syndrome Clinical trials / Disease details
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. | 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 | 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 Versus Mexiletine for Non-dystrophic Myotonias | 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 |
| 2 | 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 | ||
| 3 | NCT02251457 (ClinicalTrials.gov) | August 2014 | 25/9/2014 | Study of Ranolazine in Myotonia Congenita, Paramyotonia Congenita and Myotonic Dystrophy Type 1 | Open Label Trial of Ranolazine in Myotonia Congenita, Paramyotonia Congenita, & Myotonic Dystrophy Type 1 | Myotonia Congenita;Paramyotonia Congenita;Myotonic Dystrophy 1 | Drug: Ranolazine | Ohio State University | Gilead Sciences | Completed | 18 Years | 100 Years | All | 35 | Phase 1 | United States |
| 4 | 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 |