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NCT00078481 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Trial of Idebenone to Treat Patients With Friedreich's Ataxia
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00078481 is a Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 16 participants.
The verdict
NCT00078481, a Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study will determine the highest amount of idebenone that can be taken without harmful side effects in children, teenagers, and adults with Friedreich's ataxia, a progressive degenerative disease that affects several body systems. Studies in France and Canada showed that patients with Friedreich's ataxia who took idebenone had a decrease in the size of their left ventricle (main pumping chamber of the heart), which is often enlarged in this disease. It is possible that idebenone may also prevent the progression of nervous system degeneration in Friedreich's ataxia. Patients 5 years of age and older with Friedreich's ataxia may be eligible for this study. Candidates are screened with a blood test and review of their medical records, including genetic studies. Participants undergo the following procedures during a 6-day hospital admission to the NIH Clinical Center: * Placement of an intravenous catheter (plastic tube inserted into a vein) for collecting blood samples after drug administration * Blood and urine tests * Heart examination, including electrocardiogram (EKG), to assess heart function and size. * Idebenone therapy: Patients take three tablets a day (at 7 AM, 1 PM and 7 PM) on days 2, 3 and 4 of hospitalization. Blood samples are collected through the IV tube at 0.5, 1, 2, 4, and 6 hours after the first dose on day 2, then at 1 hour after the first and third doses every day, and then at 1, 2, 4, 8, 12, 24, 36, and 48 hours after the last dose on day 4 to determine how the body uses and eliminates the drug. * Monitoring for drug side effects: Patients have frequent checks of vital signs (blood pressure, pulse, temperature, breathing rate) and a brief physical examination to check for drug side effects from the start of drug therapy on day 2 until at least 43 hours after the last dose on day 4. Patients who experience no difficulties are discharged from the hospital after the sixth day with a 1-month supply of medication to take 3 times a day at home
Interventions
- DRUG Idebenone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2004-02 |
| Est. Completion | 2006-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078481
The ClinicalTrials.gov registry entry for NCT00078481 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 Idebenone is the first listed.
NCT00078481 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00078481 about?
NCT00078481 is a clinical study titled "Phase 1 Trial of Idebenone to Treat Patients With Friedreich's Ataxia". This study will determine the highest amount of idebenone that can be taken without harmful side effects in children, teenagers, and adults with Friedreich's ataxia, a progressive degenerative disease that affects several body systems. Studies in France and Canada showed that patients with Friedreic...
What is the current status of trial NCT00078481?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2004-02. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00078481?
The interventions under investigation include: Idebenone (DRUG).
Who is sponsoring clinical trial NCT00078481?
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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