A Phase 2 interventional study of Mexiletine in Blepharospasm, Dystonia and Spasm, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Phase 2, Interventional, and Treatment
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.
42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.
This study's enrollment of 24 is below the median of 40 across 28 interventional studies indexed under Blepharospasm.
Browse Blepharospasm studies →National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 601 studies on the registry; 56 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
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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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The record gives a start of Jul 1998 and a completion of Jul 2002. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2002. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mexiletine
National Institute of Neurological Disorders and Stroke (NINDS) →