Dystonia Clinical Trial
Official title:
Mexiletine for the Treatment of Focal Dystonia
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | July 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Neurological Disorders and Stroke (NINDS) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Hallett M. Is dystonia a sensory disorder? Ann Neurol. 1995 Aug;38(2):139-40. — View Citation
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. — View Citation
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. — View Citation
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