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Blockade of chemokine signaling in patients with multiple sclerosis

F. Zipp, MD^*, H. P. Hartung, MD, J. Hillert, MD, S. Schimrigk, MD, C. Trebst, MD, M. Stangel, MD, C. Infante-Duarte, PhD, P. Jakobs, Dipl.Math, C. Wolf, MD, R. Sandbrink, MD, C. Pohl, MD, M. Filippi, MD^* for the CCR1 Antagonist Study Group

From the Institute of Neuroimmunology, Charité–Universitätsmedizin (F.Z., C.I-D.), Berlin, Germany; Department of Neurology, Heinrich-Heine-Universität (H-P.H.), Düsseldorf, Germany; Neurotec Department, Karolinska Institute (J.H.), Stockholm, Sweden; Department of Neurology, St Josef Hospital (S.S.), Ruhr-Universität Bochum, Germany; Department of Neurology, Medical School (C.T., M.S.), Hannover, Germany; Schering AG (P.J., C.W., R.S., C.P.), Berlin, Germany; Department of Neurology, University Hospital (C.P.), Bonn, Germany; and Neuroimaging Research Unit, Department of Neurology, Scientific Institute and University HSR (M.F.), Milan, Italy.

Address correspondence and reprint requests to Frauke Zipp, Professor of Neuroimmunology, Institute of Neuroimmunology, Neuroscience Research Center, NWFZ 2680, Charité, 10098 Berlin, Germany; e-mail: frauke.zipp{at}charite.de

We assessed the safety and efficacy of orally administered CC chemokine receptor 1 (CCR1) antagonist in 105 patients with relapsing/remitting MS (RRMS) in a 16-week, randomized, double-blind, placebo-controlled trial. The primary endpoint was the cumulative number of newly active lesions on serial MRI scans. Other MRI, immunologic, and clinical outcomes were also explored. No significant treatment difference was observed for any tested MRI variable. CCR1 does not contribute to initial leukocyte infiltration in RRMS.

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* These authors contributed equally to the design and conduct of the study.

See appendix for a complete listing of the CCR1 Antagonist Study Group authors.

This study was funded by Schering AG and by grants from the German Ministry of Science.

Disclosure: P. Jakobs, C. Wolf, R. Sandbrink, and C. Pohl are employees of Schering AG. F. Zipp, M. Filippi, H.P. Hartung, J. Hillert, and S. Schimrigk were members of the steering committee and received consultancy fees and/or travel and research grants from Schering and/or other pharmaceutical companies. F. Zipp, H.P. Hartung, J. Hillert, M. Stangel, and M. Filippi have received grants in excess of $10,000 p.a. from Schering for research projects other than the present one. The authors report no conflicts of interest.

Received February 13, 2006. Accepted in final form July 24, 2006.