An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects
Condition: Spasmodic Torticollis
MeSH terms: Torticollis
Intervention: E2014 (Botulinum toxin type B); E2014 (Botulinum toxin type B) Placebo
Intervention description: 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.; 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.
Intervention MeSH terms: rimabotulinumtoxinB; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 48.0
Sex: Male
Minimum age: 20 Years
Maximum age: 44 Years
Healthy volunteers: No

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.