Mexiletine for the Treatment of Focal Dystonia

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001784
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: July 2002
  Purpose

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.


Condition Intervention Phase
Blepharospasm
Dystonia
Spasm
Drug: Mexiletine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Mexiletine for the Treatment of Focal Dystonia

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 24
Study Start Date: July 1998
Estimated Study Completion Date: July 2002
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001784

Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001784     History of Changes
Other Study ID Numbers: 980130, 98-N-0130
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Blepharospasm
Writer's Cramp
Muscle Spindle Afferents
Sodium Channels
Sensorimotor Integration
Focal Dystonia

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Blepharospasm
Eyelid Diseases
Eye Diseases
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Mexiletine
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014