Who is sponsoring NCT01406873?

NCT01406873 is sponsored by University of Rochester.

What condition does NCT01406873 study?

NCT01406873 studies Myotonic Dystrophy.

What drugs are being tested in NCT01406873?

Interventions: Mexiletine, Placebo.

What is the status of NCT01406873?

NCT01406873 is currently COMPLETED.

Last reviewed 2018-05-21 · How we verify

A Randomized, Placebo Controlled, Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type-1 (DM1)

NCT01406873 Phase 2 COMPLETED Results posted

The purpose of this study is to investigate the effects of mexiletine treatment for 6 months on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning, cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1).

Details

Lead sponsor	University of Rochester
Phase	Phase 2
Status	COMPLETED
Enrolment	42
Start date	2011-06
Completion	2017-03

Conditions

Myotonic Dystrophy

Interventions

Mexiletine
Placebo

Primary outcomes

Mean Change From Baseline in Ambulation Using the 6 Minute Walk Distance — Baseline to 6 months
During this assessment, participants were asked to walk as far as they could back and forth on a fixed 20 meter route for 6 minutes. The total distance walked during the 6 minutes was recorded in meters. Change from baseline was defined as the difference between the average 6 minute walk distance at baseline and the average 6 minute walk distance at 6 months.

Countries

United States