50
Participants
Start Date
July 31, 2013
Primary Completion Date
August 31, 2015
Study Completion Date
August 31, 2015
SPINALON (buspirone + levodopa + cardidopa)
The proposed study is a combination of 1 and 2-arm designs. First, a 2-arm design will be used, the first arm being composed of 3 subjects receiving the lowest dose of the study drug, and the second arm being composed of 1 subject receiving a placebo. This 2-arm design will be repeated consecutively (not simultaneously) with increasing doses of SPINALON, as long as the dose is well tolerated. Six (6) groups are expected to be tested with this 2-arm design.This will be followed by a 2-arm composed of 1 group with 1 subject receiving placebo and 1 larger group (10 subjects) who will receive SPINALON at MTD as identified in the previous 2-arm groups.
McGill University Health Centre (Montreal General Hospital), Montreal
United States Department of Defense
FED
Nordic Life Science Pipeline Inc.
OTHER