Subject: IVIg

From: LaVonne Murphy <[email-masked]>
Date: Mon, 25 Nov 1996 20:49:48 -0800

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Hi Gang

As promised - the info on IVIg.  And as promised, it is old.  The results 
of this study have not been made known to us yet.  Understand that it may 
not be completed.  Finding subjects that meet the criteria may have taken 
some time and it has only been about 18 months since the study began.  It 
takes 12 months to follow one client from start to finish and it is 
unlikely that the first person started medication on April 1, 1995.  Then 
it takes additional time, after all clients have finished the testing, to 
study and prepare the results for publication.

For more info, write [email-masked].  They don't have any but with enough 
requests they may go after some preliminary stuff.  Also note the address 
of Mayo.  Write there too for info if you like.  These are the guys that 
have to release the info for your edification.  (Like that 50 cent word?)

                                    L

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RESEARCH & MEDICAL PROGRAMS DEPARTMENT NEWS 
News No.: RMP 17.95
~Date: 31 March 1995

New Clinical Trial of Intravenous Immunoglobulin (IVIg) Therapy in Optic
Neuritis Associated with MS; Study Subject Recruitment Underway

Summary:  A new three-year study of intravenous immunoglobulin (IVIg) to
promote recovery of visual acuity in individuals with multiple sclerosis (MS)
who have optic neuritis will begin April 1, 1995 at the Mayo Clinic in
Rochester, Minnesota, under the direction of Dr. John Noseworthy and
colleagues.  This trial stems from earlier and ongoing National Institutes of
Health and NMSS supported studies of IVIg in animal disease that resembles MS
and in MS and will attempt to confirm a recent preliminary and uncontrolled
study suggesting that IVIg might promote visual recovery in MS patients with
optic neuritis.  The study investigators are actively recruiting participants
and information about how individuals may become involved is provided here.

Details:  Intravenous immunoglobulin (IVIg) is an intravenous preparation of
immune system proteins (antibodies) which has been shown to provide some
benefit to individuals with certain inflammatory and immune-regulated diseases
of the nervous system, including some forms of myasthenia gravis and
polyradiculopathy as well as immune-mediated muscle disorders.  In studies in
animals with an MS-like disease, treatment with similar antibodies promoted
recovery of myelin insulation around nerve fibers which had been damaged
through the disease process.  Previous uncontrolled studies in people with
optic neuritis have suggested that IVIg may help improve visual function.

These data stimulated Dr. John Noseworthy and his colleagues at the Mayo Clinic
and Foundation in Rochester, Minnesota, to initiate studies on IVIg in people
with multiple sclerosis.  The National Multiple Sclerosis Society funded an
initial pilot study in which showed that IVIg could be administered safely to
MS patients, and now a full-scale, NIH-funded, controlled clinical trial is
underway to determine ability of IVIg to promote recovery of muscle strength in
MS patients (see Research and Medical programs Department Newssheet #RMP 31-94,
dated April 29, 1994).

Now, a new study will begin April 1, 1995, of the effects of IVIg on visual
acuity in individuals with optic neuritis associated with MS.  Participants are
being recruited for the study which will involve 60 men and women between the
ages of 18 and 49 who have clinically definite or laboratory-supported definite
MS.  To participate, an individual must have developed loss of vision in one or
both eyes of a moderate degree (visual acuity worse than 20/40) which has not
recovered within a six-month period from onset.  This level of visual loss must
have been recently stable with no spontaneous worsening or improvement.

The study will be placebo-controlled and double-blinded (neither patients in
the study nor physicians will know who is on active treatment and who is on
inactive placebo).  Half of the patients in the study will receive IVIg and
half will receive placebo, injected intravenously daily for five days with
repeat treatments thereafter, once a month for three months (total" 8
infusions).  Repeat clinical evaluations will be performed at 3, 6, 9, and 12
months after starting treatment.  Benefit will be assessed primarily using
measures of visual function (visual acuity, visual fields, visual evoked
responses) and changes in neurological function.  All treatment and evaluation
visits will occur at the May Clinic's St. Mary's Hospital in Rochester,
Minnesota.

All medical and hospital costs associated with the study visits to St. Mary's
Hospital will be paid by the study organizers, with the exception of the
initial pre-enrollment consultation.  Travel costs for participants and
companions to the Rochester site will be partially subsidized by the study
organizers.  Individuals with MS-associated optic neuritis who have had a
recent onset of moderately severe visual loss and who have failed to recover
and who may be interested in participating in this new study, should consult
their personal physician and/or the May group directly at"

Intravenous Immunoglobulin Optic Neuritis Treatment Trial
Department of Neurology, West-8 A
Mayo Clinic
200 First Street, S.W.
Rochester, MN 55905

Stephen C. Reingold. Ph.D.
Vice President, Research and Medical Programs

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