At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects
In Brief
A Phase 2 clinical trial evaluating E2014 (Botulinum toxin type B) and E2014 (Botulinum toxin type B) Placebo for Spasmodic Torticollis. Completed, enrolled 48 participants across 1 site.
Detailed Summary
To evaluate inter-ethnic similarity in pharmacodynamics between Japanese and Caucasian healthy adult male subjects by comparing electrophysiological reactions after administering E2014 to extensor digitorum brevis muscle (EDB).
Study Details
Timeline
Interventions
A single-dose injection solution containing 20 units (U), 100 U, or 500 U/ 0.2 milliliters (mL) of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participants were hospitalized from a day before study treatment to Day 8 for 9 nights and 10 days, and visited at the medical institution on Days 10 and 14, and Weeks 4 and 12.
A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participants were hospitalized from a day before study treatment to Day 8 for 9 nights and 10 days, and visited at the medical institution on Days 10 and 14, and Weeks 4 and 12.