Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00102453 · ClinicalTrials.gov registry record · Phase 1
Pentoxifylline in Duchenne Muscular Dystrophy
A Phase 1 study, sponsored by Cooperative International Neuromuscular Research Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00102453 is a Phase 1 study that has completed, run by Cooperative International Neuromuscular Research Group. The registered enrollment target is 17 participants.
The verdict
NCT00102453, a Phase 1 study, has completed, sponsored by Cooperative International Neuromuscular Research Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
In this study, the primary aim will be to estimate the magnitude and variability of strength change over time that may be expected for subjects on the study treatment. This estimate of effect will allow us to develop a rigorous statistical plan in the future randomized study. The specific estimation technique to be applied will use a linear random effects model to estimate average strength change during the 3-month lead-in period and then during the twelve-month treatment period, taking into account the quantitative muscle testing (QMT) measures for each subject. Accounting for the correlation between repeated measures from each subject by using a random effects model will yield an unbiased estimate of variability for the population average change in strength. We will use an analysis of pre- and post-treatment data to inform a best estimate of treatment effect. For example, the difference in QMT trends pre- and post-treatment would provide a straightforward measure of efficacy.
Interventions
- DRUG Pentoxifylline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2002-03 |
| Est. Completion | 2007-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00102453
The ClinicalTrials.gov registry entry for NCT00102453 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cooperative International Neuromuscular Research Group, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pentoxifylline is the first listed.
NCT00102453 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00102453 about?
NCT00102453 is a clinical study titled "Pentoxifylline in Duchenne Muscular Dystrophy". In this study, the primary aim will be to estimate the magnitude and variability of strength change over time that may be expected for subjects on the study treatment. This estimate of effect will allow us to develop a rigorous statistical plan in the future randomized study. The specific estimation...
What is the current status of trial NCT00102453?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2002-03. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00102453?
The interventions under investigation include: Pentoxifylline (DRUG).
Who is sponsoring clinical trial NCT00102453?
This trial is sponsored by Cooperative International Neuromuscular Research Group, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.