UCLA researchers have begun phase II/III multi-center clinical trial1 of Estriol treatment for Relapsing Remitting Multiple Sclerosis (RRMS). Multiple sclerosis (MS) relapses are known to be significantly decreased during pregnancy as described in earlier clinical studies. This proposal will establish whether oral treatment with estriol, the major estrogen of pregnancy, induces a decrease in relapses in relapsing remitting multiple sclerosis (RRMS) subjects when used in combination with injectable Copaxone (glatiramer acetate)2. Previously, in a pilot study, it has been demonstrated that treatment of RRMS subjects with oral estriol for six months resulted in a significant reduction (approximately 80%) in gadolinium enhancing lesions on serial brain MRIs3 and caused a favorable shift in immune responses4. Current study is an add-on study aiming to extend these previous findings by treating longer and focusing on clinical outcomes. The combination of Copaxone injection plus estriol pill (8 mg per day) will be compared to Copaxone injection plus placebo pill in a double blind trial. The duration of treatment will be two years and the primary outcome measure will be relapse rate. Treatment with estriol is believed to be a neuroprotective against new MS attacks as well as to reduce severity of inflammatory reaction seen with MS. Trial is expected to be completed by July 2011 and team expect to come up with promising results which would be helpful to cut down existing expensive MS treatment with cheaper hormone pills. Recently University of Calgary team shown protective effect of hormone prolactin in preventing demyelinating episodes in animal studies.
Courtesy: EurekAlert! 22-Mar-2007
Reference:
1. A Combination Trial of Copaxone Plus Estriol in RRMS (Estriol in MS) | NCT00451204
2. Copaxone prescribing information | PDF
3. Annals of Neurology, 2002; 52:421-428
4. Journal of Immunology, 2003; 171:6267-6274
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Friday, March 23, 2007
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