Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial

Publication date: Available online 29 November 2015 Source:The Lancet Neurology Author(s): Rhonda R Voskuhl, HeJing Wang, T C Jackson Wu, Nancy L Sicotte, Kunio Nakamura, Florian Kurth, Noriko Itoh, Jenny Bardens, Jacqueline T Bernard, John R Corboy, Anne H Cross, Suhayl Dhib-Jalbut, Corey C Ford, Elliot M Frohman, Barbara Giesser, Dina Jacobs, Lloyd H Kasper, Sharon Lynch, Gareth Parry, Michael K Racke, Anthony T Reder, John Rose, Dean M Wingerchuk, Allan J MacKenzie-Graham, Douglas L Arnold, Chi Hong Tseng, Robert Elashoff Background Relapses of multiple sclerosis decrease during pregnancy, when the hormone estriol is increased. Estriol treatment is anti-inflammatory and neuroprotective in preclinical studies. In a small single-arm study of people with multiple sclerosis estriol reduced gadolinium-enhancing lesions and was favourably immunomodulatory. We assessed whether estriol treatment reduces multiple sclerosis relapses in women. Methods We did a randomised, double-blind, placebo-controlled phase 2 trial at 16 academic neurology centres in the USA, between June 28, 2007, and Jan 9, 2014. Women aged 18–50 years with relapsing-remitting multiple sclerosis were randomly assigned (1:1) with a random permuted block design to either daily oral estriol (8 mg) or placebo, each in combination with injectable glatiramer acetate 20 mg daily. Patients and all study personnel, except for pharmacists and statisticians, wer...
Source: The Lancet Neurology - Category: Neurology Source Type: research