20 completed, 4 recruiting, 3 unknown, 1 terminated. 10 Phase 2, 9 Phase 3, 4 Not applicable, 3 Phase 4, 2 Phase 1.
Follow Mexiletine: new trials by email Literature Review of Mexiletine trials Research Report on Mexiletine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Prospective, Long Term, Observational Study (Patient Registry) of Paediatric Myotonic Disorders Mexiletine - Myotonic Disorders | Recruiting | Lupin Ltd. | 10 | 2025-09-30 | 2025-09-23 | |
| An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR Granular powder in unit dose foil-lined sachet Mexiletine (PR), Oral Capsule Mexiletine (IR) - Myotonia | Phase 3 | Recruiting | Lupin Ltd. | 24 | 2025-09-03 | 2025-12-22 |
| Non-Invasive Programmed Stimulation (NIPS) to Guide the Subsequent VT Therapeutic Strategies Re-Do ventricular tachycardia ablation, Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine) - Ventricular Tachycardia (VT) | Not applicable | Recruiting | IRCCS Ospedale San Raffaele | 51 | 2025-06-12 | 2026-03-27 |
| Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy Mexiletine hydrochloride, Placebo - Spinal and Bulbar Muscular Atrophy | Phase 2 / Phase 3 | Recruiting | Masahisa Katsuno | 68 | 2025-02-28 | 2025-04-16 |
| The Effect of Late Na Current Blocker Mexiletine on Giant T-wave Electrical Alternans(STOP-TWA) Mexiletine, Conventional therapy - Giant T-wave Electrical Alternans | Not applicable | Unknown | First Affiliated Hospital Xi'an Jiaotong University | 50 | 2023-01-01 | 2024-04-04 |
| Treatment of Myotonia - Lamotrigine Versus Namuscla Lamotrigine, Namuscla - Non-Dystrophic Myotonia | Not applicable | Unknown | Grete Andersen, MD | 32 | 2022-12-05 | 2022-12-06 |
| Open-label Extension Study in Paediatric Patients Who Have Completed the MEX-NM-301 Study. Mexiletine - Myotonic Disorders | Not applicable | Completed | Lupin Ltd. | 12 | 2021-11-05 | 2026-09-08 |
| Study to Investigate the Efficacy and Safety of Mexiletine in Patients With Myotonic Dystrophy Type 1 and Type 2 Mexiletine 167 mg, Placebo - Myotonic Dystrophy Type 1 and Type 2 | Phase 3 | Withdrawn | Lupin Ltd. | 2021-09-03 | 2024-05-06 | |
| Open Label Study in Adolescents and Children With Myotonic Disorders Mexiletine - Myotonic Dystrophy | Phase 3 | Completed | Lupin Ltd. | 12 | 2021-09-03 | 2024-11-25 |
| MExiletine Versus Lamotrigine in Non-Dystrophic Myotonias Mexiletine, Lamotrigine 25Mg Oral Tablet, Extended Release - Non-Dystrophic Myotonia | Phase 3 | Unknown | University College, London | 60 | 2021-08-12 | 2022-11-02 |
| An Observational Study in Adult Patients With Non-dystrophic Myotonic Disorders Mexiletine - Myotonic Dystrophy | Completed | Lupin Ltd. | 53 | 2020-12-17 | 2026-06-22 | |
| Mexiletine in Sporadic Amyotrophic Lateral Sclerosis Mexiletine, Placebo - Sporadic Amyotrophic Lateral Sclerosis | Phase 2 | Completed | University of Washington | 20 | 2016-10-01 | 2019-12-05 |
| Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease Placebo, Mexiletine - Charcot Marie Tooth Disease | Phase 2 | Completed | University of Rochester | 4 | 2015-09-01 | 2018-03-26 |
| Anti-arrhythmic Therapy vs Catheter Ablation as First Line Treatment for AICD Shock Prevention Antiarrhythmic Drug Therapy, Catheter ablation - Ventricular Tachycardia, Ventricular Arrhythmia | Phase 4 | Terminated | Ottawa Heart Institute Research Corporation | 3 | 2014-10-01 | 2026-05-04 |
| Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations Nortriptyline, Duloxetine, Pregabalin - Cryptogenic Sensory Polyneuropathy | Phase 4 | Completed | University of Kansas Medical Center | 402 | 2014-10-01 | 2018-07-06 |
| Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block Dofetilide, Mexiletine, Lidocaine - Drug-induced QT Prolongation, Pharmacokinetics | Phase 1 | Completed | Food and Drug Administration (FDA) | 22 | 2014-05-01 | 2016-06-08 |
| Combined N-of-1 Trials Mexiletine vs Placebo in Patients With Non-Dystrophic Myotonia (NDM) Mexiletine, Placebo - Non Dystrophic Myotonia | Phase 2 | Completed | Radboud University Medical Center | 30 | 2014-01-01 | 2016-01-26 |
| Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS) Mexiletine, Placebo - Sporadic Amyotrophic Lateral Sclerosis | Phase 2 | Completed | University of Washington | 75 | 2013-07-01 | 2021-09-29 |
| Mexiletine for the Treatment of Muscle Cramps in ALS Mexiletine, Placebo - Muscle Cramps in Amyotrophic Lateral Sclerosis | Phase 4 | Completed | Bjorn Oskarsson, MD | 23 | 2013-05-01 | 2017-08-28 |
| Effects of Mexiletine on Colonic Transit in a Patient With Irritable Bowel Syndrome - Constipation (IBS-C) Mexiletine - IBS | Phase 1 | Completed | Mayo Clinic | 1 | 2012-10-01 | 2013-10-01 |
Showing 20 of 29. Sign in to see all of them.
Myotonic Disorders (4) · Myotonic Dystrophy (4) · Pain (3) · Tachycardia, Ventricular (3) · Amyotrophic lateral sclerosis 1 (2) · Arrhythmias, Cardiac (2) · Cardiovascular Diseases (2) · Heart Diseases (2) · Myotonia (2) · Ventricular Fibrillation (2) · AIDS-Related Complex (1) · Acquired Immunodeficiency Syndrome (1) · Agnosia (1) · Amyotrophic Lateral Sclerosis (1) · Blepharospasm (1)
Lupin Ltd. (6) · University of Washington (3) · University of Rochester (2) · Assistance Publique - Hôpitaux de Paris (1) · Bjorn Oskarsson, MD (1) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (1) · First Affiliated Hospital Xi'an Jiaotong University (1) · Food and Drug Administration (FDA) (1) · Grete Andersen, MD (1) · IRCCS Ospedale San Raffaele (1) · Masahisa Katsuno (1) · Mayo Clinic (1) · National Center for Research Resources (NCRR) (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · National Institute of Neurological Disorders and Stroke (NINDS) (1)
United States (10) · France (5) · Canada (3) · United Kingdom (3) · Italy (2) · Belgium (1) · China (1) · Denmark (1) · Germany (1) · Japan (1) · Netherlands (1) · Tanzania (1)
Bertrand Fontaine, MD, PhD (1) · Bjorn Oskarsson, MD (1) · Carlos Sanabria, MD (1) · Catharine Sarret, MD (1) · D Simpson (1) · David Herrmann, MD (1) · Dr. G Drost, MD, PhD (1) · Drs. B Schouwenberg, MD (1) · Drs. BC Stunnenberg, MD (1) · Drs. H Groenewoud, MSc (1) · Drs. J Raaphorst, MD (1) · Drs. J Timmermans, MD (1) · Drs. N van Alfen, MD, PhD (1) · Drs. W Woertman, PhD (1)
PMID 18648238, PMID 23032552, PMID 24613995, PMID 25740836, PMID 25880166, PMID 26259627, PMID 27577191, PMID 28036330, PMID 28036334, PMID 29545359, PMID 30535218, PMID 31221360, PMID 32599177, PMID 32809014, PMID 39304240
R01HL031472 (1), R01HL034071 (1)