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

NCT ID: NCT00280384

Last Updated: 2013-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31

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 digitorum brevis muscle (EDB).

Conditions

Spasmodic Torticollis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

E2014 (Botulinum toxin type B)

Group Type: ACTIVE_COMPARATOR

E2014 (Botulinum toxin type B)

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

E2014 (Botulinum toxin type B) Placebo

Intervention Type: 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.

Interventions

E2014 (Botulinum toxin type B)

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.

Intervention Type: DRUG

E2014 (Botulinum toxin type B) Placebo

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 Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Eisai Limited

INDUSTRY

Sponsor Role: lead

Principal Investigators

Hiroki Shimizu

Role: STUDY_DIRECTOR

Eisai Co., Ltd.

Locations

Kagoshima, Kagoshima-ken, Japan

Countries

Japan

Other Identifiers

E2014-J081-133

Identifier Type: -

Identifier Source: org_study_id