Clinical trial NCT00280384: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spasmodic Torticollis
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-23
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion criteria:

1. Participants aged between 20 and 44 years at the time of obtaining informed consent.
2. 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.
3. 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.
4. 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:

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.

Primary outcomes:
measure: Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From Baseline
timeFrame: Baseline and Up to Week 12
measure: Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude at Baseline
timeFrame: Baseline
measure: Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Area Reduction From Baseline
timeFrame: Baseline and Up to 12 Weeks
measure: Extensor Digitorum Brevis (EDB) Muscle M-Wave Area At Baseline
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kagoshima
country: Japan
state: Kagoshima-prefecture
Study officials:
affiliation: Eisai Co., Ltd.
name: Hiroki Shimizu
role: STUDY_DIRECTOR
References: