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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004682
Recruitment Status : Terminated
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:


I. Determine whether intravenous immunoglobulin is an effective therapy for patients with mild or moderate myasthenia gravis.

Condition or disease Intervention/treatment Phase
Myasthenia Gravis Drug: immune globulin Not Applicable

Detailed Description:

PROTOCOL OUTLINE: This study is a randomized, blinded, controlled study. Patients are stratified in both groups according to prior thymectomy (yes vs no) and by Quantitative Myasthenia Gravis Score (equal to or less than 10 vs greater than 10) so that equal numbers are assigned to each group. Patients in group 2 are also stratified as to whether they are currently on azathioprine.

Patients are randomized to receive either intravenous immunoglobulin (IVIG) for 2 days or 5% albumin (the placebo) for 2 days. A second infusion of IVIG for 1 day or albumin placebo for 1 day is given on day 22.

At the end of 6 weeks, after the randomized study, patients may choose to receive 3 additional IVIG infusions.

Patients are followed on days 1, 21, 32, and 42 of randomized or open label study.

Completion date provided represents the completion date of the grant per OOPD records

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : March 1995
Study Completion Date : March 1999

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004682

Sponsors and Collaborators
University of Texas
Study Chair: Richard J. Barohn University of Texas Identifier: NCT00004682     History of Changes
Other Study ID Numbers: 199/13250
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 1999

Keywords provided by FDA Office of Orphan Products Development:
myasthenia gravis
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Myasthenia Gravis
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs