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

Primary Purpose

Spasmodic Torticollis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
E2014 (Botulinum toxin type B)
E2014 (Botulinum toxin type B) Placebo
Sponsored by
Eisai Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasmodic Torticollis

Eligibility Criteria

20 Years - 44 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion criteria: Participants aged between 20 and 44 years at the time of obtaining informed consent. Participants whose M wave amplitude potential (between baseline and negative peak) in the EDB by stimulating peroneal nerve in the foot joints is 1 mV or more during electrophysiological examinations at the times of screening and immediately before administration. Participants who are judged to be eligible for study entry by an investigator or subinvestigator at screening and at immediately before pre-treatment medical examination. Participants who are given a full explanation about the objective and details of this study before starting screening and give written consent based on their free will. Exclusion Criteria: Participants who have a complication or history of peripheral neuropathy, nerve root impairment, muscle disease. 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. Participants who have accessory deep peroneal nerve. Participants who previously received a treatment with botulinum toxin. Participants with a history of hypersensitivity to any component of E2014 (human serum albumin, succinate buffer solution). Participants who are positive for urine drug screening at the time of screening or immediately before study drug administration. Participants who received prescription drug(s) within 1 month before study drug administration. Participants who have been treated with another investigational drug within 4 months before study drug administration. Participants who have experienced heavy exercise or hard labor within 2 weeks before study drug administration. 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. Participants who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or serologic test for syphilis (STS). Participants who received a diagnosis of acquired immunodeficiency syndrome (AIDS) or those with positive result for human immunodeficiency virus. 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. Participants who are judge to be ineligible for study entry by a principal investigator or subinvestigator.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

E2014 (Botulinum toxin type B)

E2014 (Botulinum toxin type B) Placebo

Arm Description

Outcomes

Primary Outcome Measures

Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From 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), 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
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
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
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).

Secondary Outcome Measures

Full Information

First Posted
January 20, 2006
Last Updated
April 23, 2013
Sponsor
Eisai Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00280384
Brief Title
An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects
Official Title
An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eisai Limited

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasmodic Torticollis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E2014 (Botulinum toxin type B)
Arm Type
Active Comparator
Arm Title
E2014 (Botulinum toxin type B) Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
E2014 (Botulinum toxin type B)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
E2014 (Botulinum toxin type B) Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From Baseline
Description
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.
Time Frame
Baseline and Up to Week 12
Title
Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude at Baseline
Description
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).
Time Frame
Baseline
Title
Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Area Reduction From Baseline
Description
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.
Time Frame
Baseline and Up to 12 Weeks
Title
Extensor Digitorum Brevis (EDB) Muscle M-Wave Area At Baseline
Description
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).
Time Frame
Baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participants aged between 20 and 44 years at the time of obtaining informed consent. Participants whose M wave amplitude potential (between baseline and negative peak) in the EDB by stimulating peroneal nerve in the foot joints is 1 mV or more during electrophysiological examinations at the times of screening and immediately before administration. Participants who are judged to be eligible for study entry by an investigator or subinvestigator at screening and at immediately before pre-treatment medical examination. Participants who are given a full explanation about the objective and details of this study before starting screening and give written consent based on their free will. Exclusion Criteria: Participants who have a complication or history of peripheral neuropathy, nerve root impairment, muscle disease. 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. Participants who have accessory deep peroneal nerve. Participants who previously received a treatment with botulinum toxin. Participants with a history of hypersensitivity to any component of E2014 (human serum albumin, succinate buffer solution). Participants who are positive for urine drug screening at the time of screening or immediately before study drug administration. Participants who received prescription drug(s) within 1 month before study drug administration. Participants who have been treated with another investigational drug within 4 months before study drug administration. Participants who have experienced heavy exercise or hard labor within 2 weeks before study drug administration. 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. Participants who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or serologic test for syphilis (STS). Participants who received a diagnosis of acquired immunodeficiency syndrome (AIDS) or those with positive result for human immunodeficiency virus. 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. Participants who are judge to be ineligible for study entry by a principal investigator or subinvestigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroki Shimizu
Organizational Affiliation
Eisai Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Kagoshima
State/Province
Kagoshima-prefecture
ZIP/Postal Code
890-0081
Country
Japan

12. IPD Sharing Statement

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

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