A Combination Trial of Estriol Plus Glatimer Acetate in Relapsing-Remitting Multiple Sclerosis (I7-2.002)

摘要: OBJECTIVE: Determine the effect of oral treatment with pregnancy hormone estriol in women relapsing remitting multiple sclerosis. BACKGROUND: Pregnancy is known to be a period relative protection from MS relapses. Estriol an estrogen which naturally increases high levels serum during last half pregnancy. Beneficial effects treatment, including estriol, have included both anti-inflammatory and neuroprotective mechanisms models. A small crossover pilot trial had previously shown 80% reduction white matter enhancing lesions on monthly MRIs. DESIGN/METHODS: This randomized, double-blind, multicenter, placebo-controlled (1:1) 8 mg per day RRMS women, age 18-50 years. was add-on therapy. Thus, all subjects began glatimer acetate injections within 2 months or less randomization take either versus placebo pills combination. Treatment duration The primary endpoint annualized relapse rate. Other endpoints MSFC, EDSS, MRI measures lesion activity. RESULTS: Baseline characteristics: 164 15 sites across U.S. were randomized mean 37.5 disease 3.0 99.4% at least one preceding 24 months, 29.4% having single screening MRI. EDSS score 2.2. database will locked unblinded analyses done by time presentation. Results other outcomes as well safety data. CONCLUSIONS: Effects dose induce level discussed context future development novel MS, insights understanding explored. Disclosure: Dr. Voskuhl has received personal compensation for activities Synthetic Biologics Inc. license fee payments UCLA. research support Biologics, Karo Bio. Wang nothing disclose. Wu Sicotte Bates Teva Neuroscience, Biogen Idec, Beaver Corboy ProCE speaker, Celgene Therapeutics, Novartis speaker. Novartis, BioMS, Eli Lilly & Co., Immune Tolerance Network. Cross Genzyme Corporation, GlaxoSmithKline, Inc., Hoffman-La Roche, Questcor. Roche Sanofi-Aventis Pharmaceuticals, Dhib-Jalbut Serono consultant. Ford Novartis. Acorda Corp., Ono Pharmaceutical, Diagnostics Pharmaceuticals EMD Serono, Neuroscience. Giesser9s family hold stock and/or options Idec Pfizer Giesser AVAcore Technologies. Jacobs Questcor Diagnostics, Lynch Genentech Berlex, Cognition UCB Cephalon. Pachner EMD-Serono. Hoffman-LaRoche, Racke Revalesio, editorial capacity JAMA Neurology Journal Neuroimmunology. Diogenix. Ratchford GW Sun Pharmaceuticals. Reder Bayer, Genentech, Merck Questcor, Caremark, Multiple Sclerosis Society Canada, National Society, State Illinois, Indiana. Medlink/Neurobase. Rose Idec. Wingerchuk Alexion, TerumoBCT. Burnett Tseng Elashoff