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

Spasmodic Torticollis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280384
• Other study ID #: E2014-J081-133
• Status: Completed
• Phase: Phase 2
• First received: January 20, 2006
• Last updated: April 23, 2013
• Start date: January 2006

Study information

• Verified date: April 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spasmodic Torticollis
• Torticollis

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From 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), 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.	Baseline and Up to Week 12	No
Primary	Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude at 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).	Baseline	No
Primary	Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Area Reduction From 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), 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.	Baseline and Up to 12 Weeks	No
Primary	Extensor Digitorum Brevis (EDB) Muscle M-Wave Area At 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).	Baseline	No