Baclofen Withdrawal Syndrome Clinical Trial
Official title:
Prevention of Baclofen Withdrawal Syndrome: Two-Way Crossover Study of Oral and Intravenous Baclofen in Healthy Adult Volunteers
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.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment