CLINICAL TRIALS PROFILE FOR MEXITIL

All Clinical Trials for MEXITIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01849770 ↗	Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS)	Completed	University of Washington	Phase 2	2013-07-01	The purpose of this research is to find out if mexiletine is safe and effective in people with Amyotrophic Lateral Sclerosis (ALS). In this trial, participants will be taking either 300 milligrams per day of mexiletine, 900 milligrams per day of mexiletine or placebo (non-active study drug). The safety and efficacy of these doses will be compared to see if one dose is better than the other.
NCT02045667 ↗	Combined N-of-1 Trials Mexiletine vs Placebo in Patients With Non-Dystrophic Myotonia (NDM)	Completed	ZonMw: The Netherlands Organisation for Health Research and Development	Phase 2	2014-01-01	The main objective of this study is to explore whether multiple trials with individual patients (N-of-1 trials) can produce a reliable evidence base for coverage decisions on clinical and cost-effectiveness of drug treatment for patients with rare diseases. As a case study, we will study the clinical and cost-effectiveness of Mexiletine in patients with Non-Dystrophic myotonia. The results of this analysis will be compared with the results obtained from a recently published international, multi-centre, randomized, placebo-controlled trial of Mexiletine in patients with Non-Dystrophic Myotonia (clinicaltrials.gov Identifier: NCT00832000). The secondary objective of this proposal is to assess whether mexiletine improves myotonia measured (both quantitatively and qualitative) in patients with non-dystrophic myotonia.
NCT02045667 ↗	Combined N-of-1 Trials Mexiletine vs Placebo in Patients With Non-Dystrophic Myotonia (NDM)	Completed	Radboud University	Phase 2	2014-01-01	The main objective of this study is to explore whether multiple trials with individual patients (N-of-1 trials) can produce a reliable evidence base for coverage decisions on clinical and cost-effectiveness of drug treatment for patients with rare diseases. As a case study, we will study the clinical and cost-effectiveness of Mexiletine in patients with Non-Dystrophic myotonia. The results of this analysis will be compared with the results obtained from a recently published international, multi-centre, randomized, placebo-controlled trial of Mexiletine in patients with Non-Dystrophic Myotonia (clinicaltrials.gov Identifier: NCT00832000). The secondary objective of this proposal is to assess whether mexiletine improves myotonia measured (both quantitatively and qualitative) in patients with non-dystrophic myotonia.

Clinical Trial Conditions for MEXITIL

Condition Name

Condition Name for MEXITIL
Intervention	Trials
Sporadic Amyotrophic Lateral Sclerosis	2
Drug-induced QT Prolongation	1
Non Dystrophic Myotonia	1

Condition MeSH

Condition MeSH for MEXITIL
Intervention	Trials
Sclerosis	2
Motor Neuron Disease	2
Amyotrophic Lateral Sclerosis	2

Clinical Trial Locations for MEXITIL

Trials by Country

Trials by Country for MEXITIL
Location	Trials
United States	18
Netherlands	1

Trials by US State

Trials by US State for MEXITIL
Location	Trials
Pennsylvania	2
New York	2
Massachusetts	2
California	2
Washington	2

Clinical Trial Progress for MEXITIL

Clinical Trial Phase

Clinical Trial Phase for MEXITIL
Clinical Trial Phase	Trials
Phase 2	3
Phase 1	1

Clinical Trial Status

Clinical Trial Status for MEXITIL
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for MEXITIL

Sponsor Name

Sponsor Name for MEXITIL
Sponsor	Trials
University of Washington	2
Food and Drug Administration (FDA)	1
Massachusetts General Hospital	1

Sponsor Type

Sponsor Type for MEXITIL
Sponsor	Trials
Other	6
U.S. Fed	1