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: Completed Phase 1 study, sponsored by Cooperative International Neuromuscular Research Group.
NCT00102453 is a Phase 1 study that has completed, run by Cooperative International Neuromuscular Research Group. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Quantitative muscle testing (QMT) is a technique utilized to assess muscle strength. Measurements of force are collected using a load cell while performing a maximum voluntary isometric contraction. This set-up is able to measure changes in strength of 0.25 lb which provides accurate and sensitive measurement of muscular strength. QMT is performed by a CINRG physical therapist.
Interventions
- DRUG Pentoxifylline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2002-03 |
| Est. Completion | 2007-05 |
| Phase | Phase 1 |
What the finished NCT00102453 record still lists
NCT00102453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Pentoxifylline is the first listed.
NCT00102453 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00102453's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02090140 · 17 participants · NA
Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects
- NCT03317860 · 17 participants · NA
Improving Measurement and Treatment of Post-stroke Neglect
- NCT04356469 · 17 participants · Phase 2
TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Non-Malignant Hematological Disorders in Children
- NCT04414046 · 17 participants · Phase 2
TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Primary Immunodeficiency and Inherited Metabolic Disorders in Children
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia