The primary objective of this study is to characterize baclofen pharmacokinetics following
oral and intravenous administration in patients who are on chronic oral baclofen therapy. The
secondary objective is to determine the safety profile of an IV baclofen formulation.
This study is a randomized crossover study with two treatment arms. All subjects will receive
a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether the oral or
intravenous form is given on the first study day will be randomized in a 1:1 manner.
The pharmacokinetic and tolerability information gained from this study will support the
development of further studies to assess the use of IV baclofen to prevent or treat baclofen
withdrawal syndrome.
Phase:
Phase 1
Details
Lead Sponsor:
University of Minnesota University of Minnesota - Clinical and Translational Science Institute