POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis
Status:
Unknown status
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
Multiple sclerosis (MS) affects 1 in 1000 people in western countries, mainly women in their
childbearing years. It is an autoimmune disease of the central nervous system (CNS), which
results in a chronic focal inflammatory response with subsequent demyelination and axonal
loss. Recent prospective studies reported a significant decline by two-thirds in the rate of
relapses during the third trimester of pregnancy and a significant increase by two-thirds
during the first three months post-partum by comparison to the relapse rate observed during
the year prior to the pregnancy (Confavreux et al., 1998). These dramatic changes in the
relapse rate occur at a time when the impregnation of many substances (among which, sexual
steroids) is at its highest, before a dramatic decline to the pre-pregnancy levels,
immediately following delivery.
It may be hypothesized that sexual steroids could exert beneficial effects through a
modulation of the immune state with a lowering of the pro-inflammatory lymphocyte responses
of the Th1 type and an enhancement of the anti-inflammatory responses of the Th2 type. They
may also play a direct role in the remyelination of central nervous system lesions, as they
do in the peripheral nervous system. The POPART'MUS study is a European, multicentre,
randomized, placebo-controlled and double-blind clinical trial, which aims to prevent MS
relapses related to the post-partum condition, by administering high doses of progestin
(nomegestrol acetate), in combination with endometrial protective doses of estradiol.
Treatment will be given immediately after delivery and continuously during the first three
months post-partum. Assuming the results of the trial to be positive, this new treatment
could be considered in the relapsing-remitting phase of the disease in women afar from
pregnancy and post-partum.