Clinical Trial of a New Study Drug by Neurocrine Biosciences, Inc.
Neurocrine Biosciences, Inc. is seeking up to 150 eligible patients at approximately 25 centers in North America to participate in a study to evaluate the safety, effectiveness and tolerability of a new study drug to treat relapsing forms of MS.
Location: Multi-centers throughout the US and Canada. US locations include Albuquerque, Atlanta, Columbus, Dallas, Detroit, Greensboro/Winston-Salem, Hartford, Indianapolis, Kansas City, Irvine (California), New York, Philadelphia, Phoenix, San Antonio, Sacramento, Seattle/Tacoma, St. Louis, and Wichita Falls. Canadian locations include Montreal, Halifax, Ottawa, Calgary, and Vancouver. Purpose: The purpose of this study is to evaluate the safety and tolerability of the study drug in subjects with relapsing MS, and to evaluate the effect of the study drug, as compared with placebo, on the lesions associated with MS that are seen on an MRI scan using gadolinium (Gd—a non-iodine contrast agent) to count the number of lesions. This study will also monitor the response of your immune system after treatment with the study drug.
Eligibility: Males or females aged 18 to 55 years, with a definite diagnosis of relapsing MS and a history of at least one relapse in the previous two years prior to screening. One MRI scan taken four weeks prior to randomization using a standardized MRI protocol with at least one but no more than 10 total Gd-enhancing lesions. A Kurtzke Expanded Disability Status Scale (EDSS) score of 6.5 or less. Females must not intend to conceive during or shortly after the study. They must be either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control and be willing to continue the same method of birth control during and for 30 days after the last dose of study medication. Females of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose of study drug. Males must not intend to impregnate during or shortly after the study. They must be willing to use spermicide and barrier contraception during study and for 30 days after the last dose of study medication or to provide assurance that their female partners use an acceptable method of birth control. There are further eligibility criteria and several exclusion criteria.
Procedures: The following procedures will be performed according to the study schedule of approximately 15 research visits over an 11 month period of time; study drug will be injected, MRI brain scan, chest x-ray, medical assessment tests, blood draws, electrocardiogram, vital sign measurements, urine pregnancy test (for females only), and a neurological examination (if required).
Benefit: May lead to a new treatment for RRMS.
Information: To determine if you or someone you know is eligible for this study, call toll-free 1-800-972-2505.