Phase 2
N=48
An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects
Spasmodic Torticollis
Bottom Line
View on ClinicalTrials.gov: NCT00280384 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From Baseline — 9.02; 48.53; 70.95; 81.62 Percentage of Reduction
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- E2014 (Botulinum toxin type B) (Drug); E2014 (Botulinum toxin type B) Placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Eisai Limited
- Primary completion
- Aug 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From Baseline |
9.02; 48.53; 70.95; 81.62; 14.33; 42.77 | — |
| PRIMARY Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude at Baseline |
6.67; 4.73; 4.95; 4.78; 7.12; 5.48 | — |
| PRIMARY Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Area Reduction From Baseline |
13.13; 43.22; 74.97; 79.03; 14.98; 45.65 | — |
| PRIMARY Extensor Digitorum Brevis (EDB) Muscle M-Wave Area At Baseline |
18.90; 14.97; 14.38; 14.85; 18.68; 16.18 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT00280384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.