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Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy

NCT00294658 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2017-05-23

Study results available
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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.

Conditions

Interventions

PROCEDURE

thymectomy plus prednisone

The thymectomy will be performed as soon as possible after randomization.

DRUG

prednisone alone

Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Gary Cutter, PhD · University of Alabama at Birmingham School of Public Health, Department of Biostatistics

  • Gil Wolfe, MD · University of Buffalo, Jacobs School of Medicine and Biomedical Sciences

  • Henry Kaminski, MD · George Washington University School of Medicine and Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2015-11-30
Completion
2015-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Chile
  • Germany
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • South Africa
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00294658 on ClinicalTrials.gov