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.
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.
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Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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