Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia Gravis

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT00004682
• Date of registration: 24/02/2000
• Prospective Registration: No
• Primary sponsor: University of Texas
• Public title: Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia Gravis
• Date of first enrolment: March 1995
• Target sample size: 100
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00004682
• Study type: Interventional
• Study design: Allocation: Randomized, Primary Purpose: Treatment
• Phase: N/A

Contacts

• Name: Richard J. Barohn
• Affiliation: University of Texas

Key inclusion & exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Mild or moderate generalized myasthenia gravis Grade 2 or 3
myasthenia gravis according to a modified Osserman groups system Ocular myasthenia gravis
alone or myasthenia gravis in crisis not eligible Must have elevated acetylcholine
receptor antibody titer No evidence of thymoma on chest CT or MRI No immunoglobulin-A
deficiency less than 5 mg/dL Group 1: Patients who have not received other
immunosuppressive therapy in the past, including intravenous immunoglobulin Group 2:
Patients considered steroid-dependent

Considered steroid-dependent if demonstrated improvement following initiation of
corticosteroid therapy but continue to have generalized weakness on examination despite
receiving 20 mg of prednisone (or equivalent) every other day and experience unacceptable
symptoms on lower doses Prednisone and other immunosuppressive drug doses must not have
changed within last 4 weeks May have had other immunosuppressive medication (azathioprine,
cyclosporine, cyclophosphamide) or have received plasma exchange if these treatments were
not initiated in the 2 months prior to study enrollment Must be receiving
immunosuppressive medication for at least 3 months prior to study

--Prior/Concurrent Therapy-- Endocrine therapy: Corticosteroid must be maintained at a
constant dose during study Surgery: No thymectomy in the last 3 months Other: No
plasmapheresis in the last 2 months --Patient Characteristics-- Age: 15 and over Weight:
No greater than 80% above ideal body weight Hepatic: SGOT, SGPT, and alkaline phosphatase
no greater than 1.5 times upper limit of normal (ULN) Renal: BUN no greater than ULN
Creatinine no great than ULN Neurology: No history of relevant chronic degenerative,
psychiatric, or neurologic disorder, other than myasthenia gravis, that can produce
weakness or fatigue No altered consciousness, dementia, or abnormal mental status
Pulmonary: Forced vital capacity at least 50% of predicted Not at high risk for aspiration
Other: No active thyroid gland dysfunction as manifested by abnormal thyroid function
tests or the need for current thyroid replacement Normal thyroid function tests required
No other major relevant chronic or debilitating illnesses within 6 months of study Not
pregnant or nursing Adequate contraception required of all fertile patients



Age minimum: 15 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Myasthenia Gravis

Intervention(s)

Drug: immune globulin

Secondary ID(s)

199/13250

UTSMC-FDR001362

UTSMC-039509700

Source(s) of Monetary Support

Please refer to primary and secondary sponsors