CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed
Drug / intervention
Mexiletinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001784
NCT00001784Phase 2Completed

Mexiletine for the Treatment of Focal Dystonia

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Nov 4, 1999·Updated Mar 4, 2008

In Brief

A Phase 2 clinical trial evaluating Mexiletine for Blepharospasm and 2 related conditions. Completed, across 1 site.

Detailed Summary

Dystonia refers to a condition characterized by involuntary muscle contractions that may cause pain, abnormal posture, or abnormal movements. The cause of dystonia is unknown, but some researchers believe it is a result of overactivity in the areas of the brain responsible for movement (basal ganglia). Lidocaine is a drug used for the treatment of irregular heartbeats. It is given by injection. Recent studies have shown that lidocaine is also effective for the treatment dystonia. Mexiletine is a drug similar to lidocaine used for irregular heartbeats that can be taken by mouth. Researchers would like to test the effectiveness of Mexiletine for the treatment of dystonia. Patients participating in the study will be divided into two groups; Group 1 will take Mexiletine for six weeks then stop. They will remain drug free for one week then begin taking a placebo "inactive sugar pill" for an additional six weeks. Group 2 will take a placebo "inactive sugar pill" for six weeks then stop. They will remain drug free for one week then begin taking a Mexiletine for an additional six weeks. Throughout the study researchers will test the effectiveness of the treatment by evaluating patients using clinical rating scales and neurophysiological studies. In addition, researchers will test patient's reflexes in an attempt to find out where mexiletine works in the nervous system.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartJul 1, 1998
Study CompletionJul 1, 2002
TodayJul 2, 2026
Posted 26.7 years ago

Interventions

Mexiletinedrug