Mexiletine for the Treatment of Focal Dystonia

Learn more about:
Related Clinical Trial
Data Analysis of Protocol 04-N-0188: Neurophysiological Markers in Patients With Craniofacial Dystonia and Their Relatives Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm Mexiletine for the Treatment of Focal Dystonia A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm A Retrospective Chart Review of BOTOX® and Xeomin® for the Management of Cervical Dystonia and Blepharospasm An RCT of a Patient-initiated Treatment Service for BEB and HFS Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm Photic Blink Reflex in People With Blepharospasm and Increased Blinking IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm Blepharospasm Short Interval Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm Brain Changes in Blepharospasm Blepharospasm Patient Survey for Patients With Blepharospasm A Mechanical Device for Blepharospasm Blepharospasm Tools Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States

Brief Title

Mexiletine for the Treatment of Focal Dystonia

Official Title

Mexiletine for the Treatment of Focal Dystonia

Brief 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.
    

Detailed Description

      Dystonia is a complex neurological disorder with an unknown pathogenesis likely involving the
      basal ganglia. There is no adequate treatment for dystonia. Recent studies using
      intramuscular and intravenous lidocaine have shown improvement in dystonic movements. It has
      been proposed that patients with dystonia have reduced presynaptic inhibition of alpha
      motoneurons leading to overactivation in response to movement. This may also reflect a
      hyperexcitability at the cortical level, which can be reduced by altering peripheral input.

      Mexiletine, an antiarrhythmic similar to lidocaine, but available orally, may benefit
      patients with dystonia, as has been shown in several recent open-label studies. This trial
      offers the possibility of treating dystonia as well as further elucidating the level of
      dysfunction in the nervous system in dystonic patients. We propose a double-blind cross over
      study comparing mexiletine to placebo in the treatment of patients with idiopathic dystonia.
      The patients will be evaluated by clinical rating scales as well as neurophysiological
      studies. In order to study the physiologic effect and attempt to localize the neuroanatomic
      sight of action of mexiletine, studies of peripheral reflexes, reciprocal inhibition and
      cortical excitation will be performed. These studies will include blink reflex recovery
      curves, tonic vibration reflex, H-reflex and transcranial magnetic stimulation.
    

Study Phase

Phase 2

Study Type

Interventional




Condition

Blepharospasm

Intervention

Mexiletine


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

July 1998

Completion Date

July 2002


Eligibility Criteria

        INCLUSION CRITERIA:

        Patients with focal dystonia, specifically writer's cramp and blepharospasm, will be
        eligible for study.

        Patients will need medical clearance, specifically, cardiac clearance, by their primary
        care physician. This will include an EKG within the past 12 months and no history of
        underlying cardiac disease.

        EXCLUSION CRITERIA:

        Patients with any of the following conditions will be excluded from the study: structural
        brain lesions, identifiable etiology for dystonia (such as stroke, trauma, Parkinson's
        Disease, Wilson's Disease, or peripheral neuropathy), contractures or fixed joint
        deformities, current or past use of neuroleptics, seizures, prior neurosurgery, or
        co-existent neurologic or general medical illness, including history of cardiovascular
        disease or peptic ulcer disease and pregnant or breast-feeding women.

        Patients who are taking or have taken mexiletine will be excluded as well.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00001784

Organization ID

980130

Secondary IDs

98-N-0130


Study Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)


Study Sponsor

, , 


Verification Date

July 2002