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Completed

NCT Number: NCT00280384

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

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).

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Key information

Conditions

Spasmodic Torticollis Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Kagoshima, Kagoshima-ken, 890-0081, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E2014 (Botulinum toxin type B)

Drug

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.

E2014 (Botulinum toxin type B) Placebo

Drug

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 outcomes

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

    Time frame: Baseline and Up to Week 12

    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.

  2. Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude at Baseline

    Time frame: 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).

  3. Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Area Reduction From Baseline

    Time frame: Baseline and Up to 12 Weeks

    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.

  4. Extensor Digitorum Brevis (EDB) Muscle M-Wave Area At Baseline

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Eisai Limited

Industry

Registry information

Important dates

Study start
2006
Primary completion
2006
First posted
Jan 23, 2006
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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