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NCT00005925 · ClinicalTrials.gov registry record · Phase 1
Brain Infusion of Muscimol to Treat Epilepsy
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00005925 is a Phase 1 study that was terminated before completion, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 3 participants.
The verdict
NCT00005925, a Phase 1 study, was terminated before completion, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of infusing a chemical called muscimol into the brain to control seizures in patients with intractable epilepsy (frequent seizures that persist despite therapy). Muscimol, which is similar to a naturally occurring brain chemical called GABA, has been shown to reduce seizures in rats. After the infusion study, patients will undergo a standard surgical procedure for controlling seizures. Patients 18 years of age or older with intractable epilepsy may be eligible for this study. Before entering protocol 00-N-0158, candidates will be screened under protocol 01-N-0139, Evaluation and Treatment of Patients with Epilepsy, with a medical history, physical and neurologic examination, chest X-ray, electrocardiogram, blood and urine tests, electroencephalographic (EEG) monitoring and magnetic resonance imaging (MRI) of the head. Patients enrolled in this study will have the following procedures: 1. Computerized tomography (CT) and magnetic resonance imaging (MRI) of the head to guide catheter/electrode placement (see #2). 2. Depth catheter/electrode placement into the presumed location of the seizure focus (the part of the brain where the seizures originate) - A small hole is drilled through the skull. A depth electrode with a hole in the center of the tubing is passed through the brain into the structures usually involved in intractable epilepsy. MRI will be done to check electrode placement. Video-EEG monitoring will continue for 5 days for this part of the study. Patients will be tested for their ability to understand and produce speech, see normally, move their arms and legs, distinguish sharp and dull objects, and put pegs in a pegboard. They will be questioned about headache, weakness, numbness or sleepiness. The electrode will be left in place for muscimol infusion (see #3). 3. Muscimol infusion - Into the seizure focus, patients will be given two infusions-one of saline (salt water) alone and one of muscimol dilut
Interventions
- DRUG Muscimol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2000-06-23 |
| Est. Completion | 2014-12-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005925
The ClinicalTrials.gov registry entry for NCT00005925 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 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 Muscimol is the first listed.
NCT00005925 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00005925 about?
NCT00005925 is a clinical study titled "Brain Infusion of Muscimol to Treat Epilepsy". This study will examine the safety and effectiveness of infusing a chemical called muscimol into the brain to control seizures in patients with intractable epilepsy (frequent seizures that persist despite therapy). Muscimol, which is similar to a naturally occurring brain chemical called GABA, has b...
What is the current status of trial NCT00005925?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2000-06-23. Estimated completion is 2014-12-24.
What interventions are being tested in trial NCT00005925?
The interventions under investigation include: Muscimol (DRUG).
Who is sponsoring clinical trial NCT00005925?
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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