SUMMARY
The first large-scale trial of a sex hormone
for the treatment of MS is about to begin at
seven research centres in the United States.
Women newly diagnosed with relapsing-remitting
MS will be recruited at seven medical centres
across the United States in the near future.
If successful, this clinical trial will lay
the groundwork for a larger, definitive trial
that could lead to a new treatment option for
women with MS. Its results may also have implications
for women with other autoimmune diseases, such
as rheumatoid arthritis.
DETAILS
In the first effort of its kind in MS, neurologist
Dr. Rhonda Voskuhl at the University of California
at Los Angeles (UCLA) is leading a team of
investigators
to conduct a two-year, controlled clinical trial of the female sex hormone
estriol involving 130 women with early relapsing-remitting multiple sclerosis.
In Canada, research has found that MS affects women three times as often as
men. Gender differences were the centre of a special, five-year research initiative
by the National MS Society (USA). Among findings from the 50 projects supported
through this $10 million initiative was the possibility that the female hormone
estriol may help protect against the immune attacks that underlie MS. Estriol
levels rise significantly during pregnancy, when most women’s MS disease
activity declines. This led some to suspect that estriol may be responsible
for this easing of symptoms during pregnancy.
According to Dr. Voskuhl, in using estriol they “aim to simulate some
of the disease protection offered by pregnancy. We are very enthusiastic about
this new agent since it has decades of known safety and since it will be given
as a pill, not a shot.” Dr. Voskuhl and others explored this lead in
mice with an MS-like disease, She also conducted a small, early-phase trial
of estriol in 12 women with MS. The results showed decreases in disease activity
during estriol treatment in women with relapsing-remitting MS.
The two-year study is planned as a double-blind, placebo-controlled trial that
will take place at seven sites in the United States (in Los Angeles, St. Louis,
New Brunswick (NJ), Columbus, Chicago, Salt Lake City and Detroit). When the
centres are ready to recruit trial participants, detailed location and contact
information will be posted for those who’d like to determine if they
are eligible. No Canadian clinical research centres are involved.
Investigators will administer estriol in pill form in combination with subcutaneously
(under the skin) injected Copaxone, a standard treatment for MS, for two years.
The team will evaluate effects of the treatment combination on relapse rates
and several clinical and magnetic resonance imaging measures of disability
progression.
If successful, this clinical trial will lay
the groundwork for a larger, definitive trial
that could lead to a new treatment option for
women with MS. Its results may also have implications
for women with other autoimmune diseases, such
as rheumatoid arthritis.
[With information from the National MS Society
(USA)]
ASK MS Information System Code: 2.6.3.b
National Research Department
National Marketing and Communications Department
