Estrogen combination for treatment of multiple sclerosis
View Patent ↗Provided are methods for treating multiple sclerosis using a continuous regimen of estrogen in combination with periodic administration of a progestogen.
1. A method of improving cognition in a subject with relapsing-remitting multiple sclerosis, comprising
administering orally to a subject in need thereof, on a continuous basis for a treatment period of 84 consecutive days (12 weeks), 8 mg of estriol daily;
administering orally to the subject, for 14 consecutive days (2 weeks) of the treatment period, 0.7 mg of norethindrone daily; and
administering subcutaneously to the subject, on a continuous basis for the treatment period, 20 mg of glatiramer acetate daily,
wherein
the method comprises at least four consecutive treatment periods;
before the at least four consecutive treatment periods, the subject's PASAT score is less than 55;
after the at least four consecutive treatment periods, the subject's PASAT score is at least about 10% higher than the subject's PASAT score before the at least four consecutive treatment periods; and
the subject is a woman.
2. The method of claim 1 , further comprising an administration termination regimen following the at least four consecutive treatment periods, wherein the administration termination regimen comprises
administering to the subject, for a first period of 1-3 weeks, about 4 mg of estriol;
administering to the subject, for a second period of 1-3 weeks following the first period, about 2 mg of estriol; and,
after the second period, terminating administration of estriol to the subject.
3. The method of claim 2 , wherein the method further comprises terminating administration of the norethindrone to the subject during the first period of the administration termination regimen.
4. The method of claim 1 , wherein after the at least four consecutive treatment periods, the subject's PASAT score is at least about 25% higher than the subject's PASAT score before the at least four consecutive treatment periods.
5. The method of claim 1 , wherein the method comprises five consecutive treatment periods, six consecutive treatment periods, seven consecutive treatment periods, or eight consecutive treatment periods.
6. The method of claim 1 , wherein the estrogen and the progestogen are formulated together.
7. The method of claim 1 , wherein the subject has a uterus.
8. The method of claim 1 , wherein the subject is a premenopausal female.
9. The method of claim 1 , wherein the subject is a perimenopausal female.
10. The method of claim 1 , wherein the subject is experiencing progression of the multiple sclerosis.
11. The method of claim 1 , wherein the subject has progressive walking disability.
12. The method of claim 1 , wherein the subject is a postmenopausal female.