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NCT00005574 · ClinicalTrials.gov registry record · Phase 1
Gentamicin Treatment of Muscular Dystrophy
A Phase 1 study of Duchenne Muscular Dystrophy and Becker Muscular Dystrophy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT00005574 is a Phase 1 study of Duchenne Muscular Dystrophy and Becker Muscular Dystrophy that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 4 participants, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00005574, a Phase 1 study of Duchenne Muscular Dystrophy and Becker Muscular Dystrophy, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the antibiotic gentamicin for treating patients with muscular dystrophy caused by a specific genetic abnormality known as a nonsense mutation. In studies of mice with this type of muscular dystrophy, gentamicin treatment produced positive changes in muscle tissue. Patients with Duchenne or Becker muscular dystrophy caused by nonsense mutations by may be eligible for this 2-week study. Before starting treatment, patients will have evaluations of muscle strength and general well being. Two muscle tissue samples will be taken by needle biopsy, under local anesthetic and sedation. Because of potential risks of hearing loss and kidney toxicity associated with gentamicin, patients will also have a hearing test and blood and urine tests for kidney function before starting treatment. (Currently, gentamicin is commonly prescribed for serious infections of the lungs, heart, and digestive and urinary tracts; adverse effects of hearing loss and kidney toxicity can occur with excessively high drug doses.) Patients will be hospitalized during drug treatment. Gentamicin will be given intravenously (through a vein) once a day for 14 days. Blood samples will be collected daily to monitor drug levels and determine dosage adjustments, if necessary. Urine samples will be collected to assess kidney function. Hearing tests will be done on days 7 and 10. On the last day of the study, hearing, kidney function, and muscle strength will be tested and the results compared with pre-treatment levels. Blood and muscle samples will also be taken again for pre-treatment comparison. Hearing, blood, urine, and muscle strength tests will be repeated one month after treatment ends for comparison with previous results.
Conditions Studied
Interventions
- DRUG Gentamicin
Study Locations (1)
Maryland
- National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2000-02 |
| Est. Completion | 2001-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005574
The ClinicalTrials.gov registry entry for NCT00005574 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (99% lower). 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 2 conditions, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which Gentamicin is the first listed.
NCT00005574 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00005574 about?
NCT00005574 is a clinical study titled "Gentamicin Treatment of Muscular Dystrophy". This study will evaluate the antibiotic gentamicin for treating patients with muscular dystrophy caused by a specific genetic abnormality known as a nonsense mutation. In studies of mice with this type of muscular dystrophy, gentamicin treatment produced positive changes in muscle tissue. Patients ...
What is the current status of trial NCT00005574?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2000-02. Estimated completion is 2001-01.
What conditions does trial NCT00005574 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy, Becker Muscular Dystrophy.
What interventions are being tested in trial NCT00005574?
The interventions under investigation include: Gentamicin (DRUG).
Who is sponsoring clinical trial NCT00005574?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00005574 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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