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A Phase I, Randomized, Double-Blind, Laser-Evoked Potential Study to Evaluate the Analgesic/Antihyperalgesic Effect of ASP9226, a State-Dependent N-Type Voltage-Gated Calcium Channel Inhibitor, in Healthy Male Subjects.


ABSTRACT: Objective:Evaluate the analgesic/antihyperalgesic effects of ASP9226, a state-dependent N-type voltage-gated calcium channel inhibitor, in healthy male subjects. Design:Randomized, double-blind, double-dummy, placebo- and active comparator-controlled crossover study. Setting:HPR Dr. Schaffler GmbH, Munich, Germany. Subject:Healthy male subjects aged 18-55?years. Methods:Twenty-four eligible subjects were randomly assigned to one of four treatment sequences and received single doses of ASP9226 (30?mg or 50?mg), pregabalin (150?mg), or placebo during four treatment periods. Laser-evoked potentials (LEP) and postlaser pain visual analog scales (VAS) on capsaicin-treated skin were assessed during main assessment days (the first day of each study period). Primary and secondary end points were the differences in LEP N2-P2 peak-to-peak (PtP) amplitudes and VAS score, respectively, in all subjects. Results:Overall, treatment with pregabalin resulted in a significantly lower LEP N2-P2 PtP amplitude vs placebo (-3.30??V, P?

SUBMITTER: Schaffler K 

PROVIDER: S-EPMC6217710 | BioStudies | 2018-01-01T00:00:00Z

REPOSITORIES: biostudies

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