A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis (ASCEND SPMS).
Location of Study/Trial :
16 Hayden Ave,
Lexington, MA 02421
41 Mall Road
Burlington, MA 01805
18-58 years of age
EDSS including and between 3.0 and 6.5
SPMS 2+ years, confirmed disease progression in the last one year
Clinical relapse in last 3 months
Timed-25-foot-walk done in greater than 30 seconds.
HIV positive, Hepatitis C positive, Hepatitis B positive
Prior treatment with Tysabri
Prior treatment with cell-depleting therapies
Pregnant or currently breast-feeding
Ann Camac, MD, Lahey Clinic MS Center
In light of lack of therapy for SPMS patients, the study seeks to determine whether or not Natalizumab is effective in slowing disease progression. Patients will be randomized to either Natalizumab or Placebo in a 1:1 ratio. Placebo use is justified since there are no proven treatment options for SPMS patients. The study duration is 108 weeks and patients will be on study drug treatment for 96 weeks. Study drug will be administered once a month intravenously. Patients will come in for study visits once every 12 weeks (some of which will coincide with standard of care visits), which include neurological examination, EDSS assessment, physical examination, blood draw and urine sample collection, Timed-25-foot-walk test, 9-hole-peg test, 6-minute-walk test, Brain MRI, symbol digit modality test, and response to questionnaires regarding quality of life measures.