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NCT00294658 · ClinicalTrials.gov registry record · Phase 3
Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy
A Phase 3 study of Myasthenia Gravis, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 3
- Development phase
- 126
- Enrollment target
- 20
- Study locations
NCT00294658: Completed Phase 3 study of Myasthenia Gravis, sponsored by University of Alabama at Birmingham.
NCT00294658 is a Phase 3 study of Myasthenia Gravis that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 126 participants, below the 187-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00294658, a Phase 3 study of Myasthenia Gravis, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 126 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to determine if thymectomy combined with prednisone therapy is more beneficial in treating non-thymomatous myasthenia gravis than prednisone therapy alone.
Primary Outcome
Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. The time weighted average is a calculation that provides an integrated measure of the outcome over the time of followup. The denominator that was used to compute the time-weighted average for the Quantitative Myasthenia Gravis (QMG) score and the prednisone dose was the number of days from randomization to the last visit. Computations used the trapezoidal method
Conditions Studied
Interventions
- PROCEDURE thymectomy plus prednisone
- DRUG prednisone alone
Study Locations (20)
California
- University of Southern California, Doheny Institute, 1450 San Pablo St - Los Angeles
- University of California Irvine, 101 The City Drive S, Bldg. 22 C, Route 13 - Orange
- California Pacific Medical Center, Castro St & Duboce Ave - San Francisco
Alabama
- University of Alabama at Birmingham, Department of Neurology, Sparks Center, Suite 350, 1720 7th Avenue South - Birmingham
- Data Coordination Center: University of Alabama at Birmingham - Birmingham
Florida
- University of Florida Jacksonville, Tower I, 8th Floor, 580 W. 8th ST. - Jacksonville
- University of Miami, 1120 NW 14th Street, Suite 1300 - Miami
Georgia
- Emory University, 201 Dowman Dr - Atlanta
- Augusta University, 1120 15th St - Augusta
Michigan
- Wayne State University School of Medicine, 4201 St Antoine, 8D UHC - Detroit
- William Beaumont Hospital, 3601 W. Thirteen Mile Road, Royal Oak - Royal Oak
Minnesota
- University of Minnesota, Department of Neurology, MMC 295, 420 Delaware St. S.E., - Minneapolis
- Mayo Clinic Rochester, 200 First St. SW - Rochester
Arizona
- Barrow Neurological Institute, Saint Joseph's Hospital and Medical Center, 350 W Thomas Rd - Phoenix
Indiana
- Indiana University, Dept of Neurology, Regenstrief Health Center, 6th floor, 1050 Walnut St, Indiana University Medical Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2006-06 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
What the finished NCT00294658 record still lists
NCT00294658 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 187-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions - of which thymectomy plus prednisone is the first listed.
NCT00294658 names 20 study sites across 13 states, led by California, Alabama, Florida.
Frequently Asked Questions
What is clinical trial NCT00294658 about?
NCT00294658 is a clinical study titled "Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy". The purpose of this trial is to determine if thymectomy combined with prednisone therapy is more beneficial in treating non-thymomatous myasthenia gravis than prednisone therapy alone.
What is the current status of trial NCT00294658?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2006-06. Estimated completion is 2015-12.
What conditions does trial NCT00294658 study?
This clinical trial studies the following conditions: Myasthenia Gravis.
What interventions are being tested in trial NCT00294658?
The interventions under investigation include: thymectomy plus prednisone (PROCEDURE), prednisone alone (DRUG).
Who is sponsoring clinical trial NCT00294658?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00294658 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00294658's enrollment target sits among peer trials
126 12th of 32 higher than 21 of 32 other Myasthenia Gravis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myasthenia Gravis 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.
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