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

Phase 2

Completed

• Conditions: Spasmodic Torticollis
• Interventions: Drug: E2014 (Botulinum toxin type B); Drug: E2014 (Botulinum toxin type B) Placebo

• Registration Number: NCT00280384
• Lead Sponsor: Eisai Limited

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-20
• Study First Submitted QC: 2006-01-20
• Study First Posted: 2006-01-23
• Primary Completion: 2006-08
• Results First Submitted: 2013-03-12
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-23
• Last Update Submitted: 2013-04-23
• Results First Posted: 2013-04-25
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

1. Participants who have a complication or history of peripheral neuropathy, nerve root impairment, muscle disease.
2. Participants with a disease that may influence the study drug evaluation, such as disorders of the gastrointestinal tract, liver, respiratory, endocrine, hematological, neurological, psychiatric and cardiovascular system, and congenital abnormality in metabolism.
3. Participants who have accessory deep peroneal nerve.
4. Participants who previously received a treatment with botulinum toxin.
5. Participants with a history of hypersensitivity to any component of E2014 (human serum albumin, succinate buffer solution).
6. Participants who are positive for urine drug screening at the time of screening or immediately before study drug administration.
7. Participants who received prescription drug(s) within 1 month before study drug administration.
8. Participants who have been treated with another investigational drug within 4 months before study drug administration.
9. Participants who have experienced heavy exercise or hard labor within 2 weeks before study drug administration.
10. Participants who underwent blood transfusion within 3 months before, those whose 400 mL of whole blood was collected within 3 months before, or those whose 200 mL of whole blood was collected within 1 month before study drug administration.
11. Participants who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or serologic test for syphilis (STS).
12. Participants who received a diagnosis of acquired immunodeficiency syndrome (AIDS) or those with positive result for human immunodeficiency virus.
13. Participants who are unwilling or unable to abide by the requirements of this study, or those who may violate the prohibitions and restrictions of this study.
14. Participants who are judge to be ineligible for study entry by a principal investigator or subinvestigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E2014 (Botulinum toxin type B)	E2014 (Botulinum toxin type B)	-
E2014 (Botulinum toxin type B) Placebo	E2014 (Botulinum toxin type B) Placebo	-

Primary Outcome Measures

Name	Time	Method
Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From Baseline	Baseline and Up to Week 12	The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave amplitude induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave amplitudes (mV) were measured at screening (baseline), and Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 14, Week 4, and Week 12. Rates of EDB M-wave amplitude reduction from baseline were then calculated at each time point. The maximum rates of EDB M-wave amplitude reduction from baseline were presented as a percentage.
Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude at Baseline	Baseline	The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave amplitude induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave amplitudes (mV) were measured at screening (baseline).
Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Area Reduction From Baseline	Baseline and Up to 12 Weeks	The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave area induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave area (mVms) was measured at screening (baseline), and Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 14, Week 4, and Week 12. Rates of EDB M-wave area reduction from baseline were then calculated at each time point. The maximum rates of EDB M-wave area reduction from baseline were presented as a percentage.
Extensor Digitorum Brevis (EDB) Muscle M-Wave Area At Baseline	Baseline	The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave area induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave area (mVms) was measured at screening (baseline).