Status:
COMPLETED
An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects
Lead Sponsor:
Eisai Limited
Conditions:
Spasmodic Torticollis
Eligibility:
MALE
20-44 years
Phase:
PHASE2
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 dig...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00280384
Start Date
January 1 2006
Last Update
April 25 2013
Active Locations (1)
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1
Kagoshima, Kagoshima-ken, Japan, 890-0081