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NCT00030134 · ClinicalTrials.gov registry record
Data Collection in Women With Fabry Disease
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 60
- Enrollment target
NCT00030134 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 60 participants.
The verdict
NCT00030134 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 60 participants
- Enrollment target
Study Summary
This protocol will collect information needed to design a clinical study for the symptoms and problems of women with Fabry disease, an inherited metabolic disorder. In this disease, an enzyme called a-galactosidase A, which normally breaks down fatty substances called glycolipids, does not function properly. The resulting accumulation of glycolipids in various tissues causes arm and leg pain, skin lesions, and problems with the kidneys, heart, nerves, and blood vessels. This protocol does not involve any experimental drug treatments, but participants may be offered enrollment in future studies and registries. Women 18 years of age and older with Fabry disease who have not had enzyme replacement therapy may participate in this study. Pregnant women are eligible, but may be excluded from certain procedures, such as magnetic resonance imaging (MRI). Participants will have the following tests and procedures over a 3-day period: * Personal and family medical history * Physical, neurological, and eye examinations * Blood and urine tests * Electrocardiogram (ECG) to measure electrical activity of the heart * Echocardiogram (ultrasound) to examine the heart muscles and pumping action * Magnetic resonance imaging (MRI) to examine the brain. This test uses a magnetic field and radio waves to produce images of the brain. The patient lies in a narrow cylinder (the MRI scanner) during the imaging and may talk with staff at any time during the procedure. * Magnetic resonance angiogram (MRA) to examine the blood vessels in the head and neck. This procedure is similar to MRI. * Genotyping to confirm the diagnosis of Fabry disease. DNA from a blood sample will be examined for the gene associated with Fabry disease. * Skin punch biopsy for microscopic examination of tissue. A piece of skin tissue about 1/8-inch thick is removed with a cookie cutter-like instrument. Participants will also complete two questionnaires regarding pain and quality of life. They will be asked to stop ta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2002-01 |
| Est. Completion | 2003-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00030134
The ClinicalTrials.gov registry entry for NCT00030134 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 60 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 0 interventions.
NCT00030134 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00030134 about?
NCT00030134 is a clinical study titled "Data Collection in Women With Fabry Disease". This protocol will collect information needed to design a clinical study for the symptoms and problems of women with Fabry disease, an inherited metabolic disorder. In this disease, an enzyme called a-galactosidase A, which normally breaks down fatty substances called glycolipids, does not function ...
What is the current status of trial NCT00030134?
This trial is currently completed. The enrollment target is 60 participants. The study started on 2002-01. Estimated completion is 2003-02.
Who is sponsoring clinical trial NCT00030134?
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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