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Phase 2 N=48 Randomized Single-blind Treatment

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

Spasmodic Torticollis

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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