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

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

August 31, 2006

Conditions
Spasmodic Torticollis
Interventions
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.

Trial Locations (1)

890-0081

Kagoshima

All Listed Sponsors
lead

Eisai Limited

INDUSTRY

NCT00280384 - An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects | Biotech Hunter | Biotech Hunter