Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001784
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Mexiletine for the Treatment of Focal Dystonia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Mexiletine for the Treatment of Focal Dystonia
Status:
COMPLETED
Status Verified Date:
2002-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients reflexes in an attempt to find out where mexiletine works in the nervous system
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 patients reflexes in an attempt to find out where mexiletine works in the nervous system
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-N-0130 | None | None | None |