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NCT00001784 · ClinicalTrials.gov registry record · Phase 2
Mexiletine for the Treatment of Focal Dystonia
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00001784 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 24 participants.
The verdict
NCT00001784, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study 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.
Interventions
- DRUG Mexiletine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 1998-07 |
| Est. Completion | 2002-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001784
The ClinicalTrials.gov registry entry for NCT00001784 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mexiletine is the first listed.
NCT00001784 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001784 about?
NCT00001784 is a clinical study titled "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 gangli...
What is the current status of trial NCT00001784?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 1998-07. Estimated completion is 2002-07.
What interventions are being tested in trial NCT00001784?
The interventions under investigation include: Mexiletine (DRUG).
Who is sponsoring clinical trial NCT00001784?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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