US2021137943A1PendingUtilityA1

Estrogen combination for treatment of multiple sclerosis

Assignee: UNIV CALIFORNIAPriority: Apr 28, 2014Filed: Oct 2, 2020Published: May 13, 2021
Est. expiryApr 28, 2034(~7.7 yrs left)· nominal 20-yr term from priority
A61K 31/567A61K 45/06A61K 31/565A61K 38/215A61K 31/566A61K 31/57A61P 37/00A61K 38/13A61P 25/00
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Claims

Abstract

Provided are methods for treating multiple sclerosis using a continuous regimen of estrogen in combination with periodic administration of a progestrogen.

Claims

exact text as granted — not AI-modified
1 - 67 . (canceled) 
     
     
         68 . 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; and   administering orally to the subject, for 14 consecutive days (2 weeks) of the treatment period, 0.7 mg of norethindrone daily;   wherein   the method comprises at least four consecutive treatment periods; and   the subject is a woman.   
     
     
         69 . The method of  claim 68 , further comprising administering a termination regimen following the at least four consecutive treatment periods, wherein the 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.   
     
     
         70 . The method of  claim 69 , wherein the method further comprises terminating administration of the norethindrone to the subject during the first period of the termination regimen. 
     
     
         71 . The method of  claim 68 , wherein the method comprises five consecutive treatment periods, six consecutive treatment periods, seven consecutive treatment periods, or eight consecutive treatment periods. 
     
     
         72 . The method of  claim 68 , wherein the estrogen and the progestrogen are formulated together. 
     
     
         73 . The method of  claim 68 , wherein the subject has a uterus. 
     
     
         74 . The method of  claim 68 , wherein the subject is a premenopausal female. 
     
     
         75 . The method of  claim 68 , wherein the subject is a perimenopausal female. 
     
     
         76 . The method of  claim 68 , wherein the subject is experiencing progression of the multiple sclerosis. 
     
     
         77 . The method of  claim 68 , wherein the subject has progressive walking disability. 
     
     
         78 . The method of  claim 68 , wherein the subject is a postmenopausal female. 
     
     
         79 . The method of  claim 68 , wherein the method further comprises administering subcutaneously to the subject, on a continuous basis for the treatment period, 20 mg of glatiramer acetate daily,

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