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 : 13 / 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 | NCT05639257 (ClinicalTrials.gov) | December 5, 2022 | 4/10/2022 | Treatment of Myotonia - Lamotrigine Versus Namuscla | Treatment of Myotonia - Lamotrigine Versus Namuscla | Non-Dystrophic Myotonia | Drug: Lamotrigine;Drug: Namuscla | Grete Andersen, MD | GCP-Copenhagen;Region Capital Denmark;Danish Region;Lupin Atlantis Holdings S.A.;ZiteLab | Recruiting | 18 Years | N/A | All | 32 | N/A | Denmark |
| 2 | 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 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 Neurology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 3 | Denmark | ||
| 3 | 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 |
| 4 | NCT01939561 (ClinicalTrials.gov) | November 2013 | 23/8/2013 | Lamotrigine as Treatment of Myotonia | Lamotrigine as Treatment of Myotonia - a Phase 3 Randomized Controlled Trial Study | Dystrophia Myotonica Type 1;Myotonia Congenita;Paramyotonia Congenita;Hyperkalemic Periodic Paralysis;Potassium-Aggravated Myotonia | Drug: Lamotrigine;Drug: Placebo | Grete Andersen, MD | NULL | Completed | 18 Years | N/A | Both | 27 | Phase 3 | Denmark |
| 5 | EUCTR2013-003309-24-DK (EUCTR) | 28/10/2013 | 21/10/2013 | Better treatment of muscle diseases | Lamotrigine 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 Andersen | NULL | Not Recruiting | Female: yes Male: yes | Denmark |