Methotrexate Therapy in Patients with Myasthenia Gravis
(MG)
Trial Status
Open for Enrollment
What is the Purpose of this Study?
To determine the safety and efficacy
of oral methotrexate therapy in patients with myasthenia gravis (MG)
who are on prednisone
Who is Eligible to Participate?
Patients 18 years and older who have
been diagnosed with generalized myasthenia gravis, according to the MGFA
classification system. Patients must be on a stable dose of at least
10mg/d of Predisone for at least 30 days prior to screening. Must be
off any other treatment for MG for at least 60 days. Patients must have
a DEXA scan in the past 6 months prior to screening. Patients must also
meet all other inclusion and exclusion criteria explained in detail by
study coordinator.
What is involved in this Study?
Patients will be randomized in a 1:1
fashion to either Methotrexate or Placebo. Patients will have blood work,
along with Physical and Neurological Exams and MG tests and questionnaires
administered at every visit.
How long is the Study?
All patients will undergo 48 weeks of study treatment.
The total study duration is approximately 50 weeks.
For More Information Contact: Nicole C. Hank, MHSM study coordinator,
at 602-258-2432 or nhank@pnal.net or call the Main line at 602-258-3354