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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2014 (Botulinum toxin type B) | Active Comparator |
| |
| E2014 (Botulinum toxin type B) Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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). |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroki Shimizu | Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kagoshima | Kagoshima-ken | 890-0081 | Japan |
Of the 94 participants screened (60 Japanese, 34 Caucasian), 57 (29 Japanese and 28 Caucasian) participants were admitted to the hospital. 9 (5 Japanese and 4 Caucasian) participants did not receive the study drug. 48 participants received the study drug (24 Japanese and 24 Caucasian) and were considered the treated population.
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| ID | Title | Description |
|---|---|---|
| FG000 | E2014 (Botulinum Toxin Type B) Placebo- Japanese | A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. |
| FG001 | E2014 (Botulinum Toxin Type B) 20 U - Japanese | A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. |
| FG002 | E2014 (Botulinum Toxin Type B) 100 U - Japanese | A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. |
| FG003 | E2014 (Botulinum Toxin Type B) 500 U - Japanese | A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. |
| FG004 | E2014 (Botulinum Toxin Type B) Placebo - Caucasian | A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. |
| FG005 | E2014 (Botulinum Toxin Type B) 20 U - Caucasian | A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. |
| FG006 | E2014 (Botulinum Toxin Type B) 100 U - Caucasian | A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. |
| FG007 | E2014 (Botulinum Toxin Type B) 500 U - Caucasian | A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | E2014 (Botulinum Toxin Type B) Placebo- Japanese | A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. |
| BG001 | E2014 (Botulinum Toxin Type B) 20 U - Japanese |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Percentage of Reduction | Baseline and Up to Week 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E2014 (Botulinum Toxin Type B) Placebo- Japanese | A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| White Blood Cell Increased | Investigations | MedDRA 9.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hiroki Shimizu, Study Director | Eisai Co., Ltd. | 81-3-3817-5235 | h3-shimizu@hhc.eisai.co.jp |
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C096323 | rimabotulinumtoxinB |
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|
| 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. |
|
| Baseline |
A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. |
| BG002 | E2014 (Botulinum Toxin Type B) 100 U - Japanese | A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. |
| BG003 | E2014 (Botulinum Toxin Type B) 500 U - Japanese | A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. |
| BG004 | E2014 (Botulinum Toxin Type B) Placebo - Caucasian | A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. |
| BG005 | E2014 (Botulinum Toxin Type B) 20 U - Caucasian | A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. |
| BG006 | E2014 (Botulinum Toxin Type B) 100 U - Caucasian | A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. |
| BG007 | E2014 (Botulinum Toxin Type B) 500 U - Caucasian | A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | E2014 (Botulinum Toxin Type B) 20 U - Japanese | A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. |
| OG002 | E2014 (Botulinum Toxin Type B) 100 U - Japanese | A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. |
| OG003 | E2014 (Botulinum Toxin Type B) 500 U - Japanese | A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. |
| OG004 | E2014 (Botulinum Toxin Type B) Placebo - Caucasian | A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. |
| OG005 | E2014 (Botulinum Toxin Type B) 20 U - Caucasian | A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. |
| OG006 | E2014 (Botulinum Toxin Type B) 100 U - Caucasian | A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. |
| OG007 | E2014 (Botulinum Toxin Type B) 500 U - Caucasian | A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. |
|
|
| 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). | Posted | Mean | Standard Deviation | EDB M-Wave Amplitude at Baseline (mV) | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Percentage of Reduction | Baseline and Up to 12 Weeks |
|
|
|
| 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). | Posted | Mean | Standard Deviation | EDB M-Wave Area at Baseline (mVms) | Baseline |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | E2014 (Botulinum Toxin Type B) 20 U - Japanese | A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. | 0 | 6 | 0 | 6 |
| EG002 | E2014 (Botulinum Toxin Type B) 100 U - Japanese | A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. | 0 | 6 | 0 | 6 |
| EG003 | E2014 (Botulinum Toxin Type B) 500 U - Japanese | A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants. | 0 | 6 | 1 | 6 |
| EG004 | E2014 (Botulinum Toxin Type B) Placebo - Caucasian | A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. | 0 | 6 | 0 | 6 |
| EG005 | E2014 (Botulinum Toxin Type B) 20 U - Caucasian | A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. | 0 | 6 | 0 | 6 |
| EG006 | E2014 (Botulinum Toxin Type B) 100 U - Caucasian | A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. | 0 | 6 | 2 | 6 |
| EG007 | E2014 (Botulinum Toxin Type B) 500 U - Caucasian | A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants. | 0 | 6 | 2 | 6 |
| Alanine Aminotransferase Increased | Investigations | MedDRA 9.0 |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA 9.0 |
|
| Eosinophil Increased | Investigations | MedDRA 9.0 |
|
| Neutrophil Increased | Investigations | MedDRA 9.0 |
|
| Neck Injury | Injury, poisoning and procedural complications | MedDRA 9.0 |
|
| Headache | Nervous system disorders | MedDRA 9.0 |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |