POPART’MUS Prevention of Post Partum Relapses with Progestin and Estradiol

INTERVENTION: Trade Name: DEMESTRIL SEPTEM Pharmaceutical Form: Transdermal patch INN or Proposed INN: Estradiol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .075‐ Pharmaceutical form of the placebo: Transdermal patch Route of administration of the placebo: Transdermal use Trade Name: LUTENYL Pharmaceutical Form: Tablet INN or Proposed INN: Nomegestrol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Multiple Sclerosis ; MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis PRIMARY OUTCOME: Main Objective: to test the hypothesis that a progestin given soon after delivery together with low doses estradiol prevent relapses in the first post partum trimester in parturing women with multiple sclerosis Primary end point(s): The primary endpoint is to compare the rate of relapses during the dirst 12 weeks after delivery, between the treated and placebo groups Secondary Objective: to assess the effect of this combination on other clinical and MRI; parameters INCLUSION CRITERIA: ‐ Multiple sclerosis according to Mac Donald criteria (including clinically syndromes fulfilling MRI criteria for MS diagnosis) ‐ Relapses‐remitting or Secondary Progressive MS ‐ EDSS ≤ 6.0 ‐ Pregnancy ≤ 36 weeks of amenorrhea Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range