HAVE YOU BEEN DIAGNOSED WITH MS AND WISH TO PARTICIPATE IN THE STUDY OF A NEW INVESTIGATIONAL DRUG?
Purpose of the Study:
The purpose of this research study is to determine the highest safe dose of the investigational drug, intravenous VX15/2503, in human subjects with MS.
Inclusion Criteria:
•Age 18- 60 years
•Definite diagnosis of MS for at least 1 year.
Exclusion Criteria:
•Treatment with any MS disease modifying therapy, other than interferon-β (Avonex®, Betaseron®, Rebif®, Extavia®) or glatiramer acetate (Copaxone®), within 3 months prior to dosing.
•Treatment with natalizumab (Tysabri®), daclizumab (Zenapax®), or fingolimod (Gilenya®) within the last 6 months prior to dosing.
•Treatment with alemtuzumab (Campath®), rituximab (Rituxan®), mitoxantrone (Novantrone®), total lymphoid irradiation, bone marrow transplant, or T cell or T cell receptor vaccination.
•Known or suspected HIV, hepatitis B, or hepatitis C infection.
•History of heart disease or myocardial infarction within 6 months prior to dosing.
The Study Includes:
– 8 to 11 study visits over 10-16 weeks; including a 24 hour hospital stay
– MRIs
– Urine and blood sampling tests
– Neurological and physical tests
Reimbursements: Travel and overnight stay reimbursements are available to study participants.
For more information about this study or to determine if you qualify, please contact
Bhavini Patel at:
Phone: 303-724-6351
Email: bhavini.patel@ucdenver.edu
Principal Investigator: Timothy Vollmer, MD
COMIRB Protocol: 13-906