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NCT00223301 · ClinicalTrials.gov registry record · Phase 2
Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00223301: Completed Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT00223301 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00223301, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
1. To determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS. 2. To document changes in exacerbation frequency, 3. To document the incidence of mild, moderate, and severe exacerbations in the treated groups (categorical analysis), 4. To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI), 5. To document changes in quality of life measures, 6. To assess fatigue with the validated fatigue assessment inventory, 7. Neuroimmunological studies:At baseline, 6 and 12 months after treatment
Interventions
- DRUG Mycophenolate Mofetil (cellcept)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2004-07 |
| Est. Completion | 2007-03 |
| Phase | Phase 2 |
What the finished NCT00223301 record still lists
NCT00223301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Mycophenolate Mofetil (cellcept) is the first listed.
NCT00223301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00223301 about?
NCT00223301 is a clinical study titled "Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis". 1. To determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS. 2. To document changes in exacerbation frequency, 3. To document the incidence of mild, moderate, and severe exacerbations in the treated groups (categorical analysis),...
What is the current status of trial NCT00223301?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2004-07. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00223301?
The interventions under investigation include: Mycophenolate Mofetil (cellcept) (DRUG).
Who is sponsoring clinical trial NCT00223301?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00223301's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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