NCT00280384

An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Eisai Limited · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Spasmodic Torticollis

Interventions

Type	Name	Description
DRUG	E2014 (Botulinum toxin type B)	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.
DRUG	E2014 (Botulinum toxin type B) Placebo	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.

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-08-01
• First posted: 2006-01-23
• Last updated: 2013-04-25
• Results posted: 2013-04-25

Locations

1 site across 1 country: Japan