Mexiletine for the Treatment of Focal Dystonia

NCT00001784 | Completed Phase 2

• 2 other identifiers: 98013098-N-0130
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Blepharospasm; Dystonia; Spasm

Keywords

Blepharospasm; Writer's Cramp; Muscle Spindle Afferents; Sodium Channels; Sensorimotor Integration; Focal Dystonia

Interventions

Mexiletine DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Hallett M. Is dystonia a sensory disorder? Ann Neurol. 1995 Aug;38(2):139-40. doi: 10.1002/ana.410380203. No abstract available.

  PMID: 7654059 BACKGROUND

• Ohara S, Miki J, Momoi H, Unno H, Shindo M, Yanagisawa N. Treatment of spasmodic torticollis with mexiletine: a case report. Mov Disord. 1997 May;12(3):466-9. doi: 10.1002/mds.870120337. No abstract available.

  PMID: 9159753 BACKGROUND

• Ikeda A, Shibasaki H, Kaji R, Terada K, Nagamine T, Honda M, Hamano T, Kimura J. Abnormal sensorimotor integration in writer's cramp: study of contingent negative variation. Mov Disord. 1996 Nov;11(6):683-90. doi: 10.1002/mds.870110614.

  PMID: 8914095 BACKGROUND

MeSH Terms

Conditions

Blepharospasm; Dystonia; Spasm; Dystonic Disorders

Interventions

Mexiletine

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Movement Disorders; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: July 1, 1998
• Study Completion: July 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-07

Locations

US (1)