| Primary | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 ("Force of EDB") After vs. Before Botulinum Toxin Injection Into EDB | The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A) or placebo. The baseline value was the mean of the 3 values for force obtained prior to injection of BoNT/A. The baseline was compared with the subsequent values. | | Posted | | Mean | Standard Deviation | kg | | Baseline (3 times) then following single injection of botulinum toxin into EDB with testing at Day 1, Day 2, Day 4, Day 14, Day 21, and Month 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin Type A, 20 Units | Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle | | OG001 | Botulinum Toxin, Type A, 2 Units | Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle | | OG002 | Placebo | Saline, Single dose, Intramuscular injection into right EDB Saline: Single Dose, Intramuscular into right EDB muscle |
| | | Title | Denominators | Categories |
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| Baseline | | | Title | Measurements |
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| - OG0007.63± 3.31
- OG0015.16± 1.48
- OG00210.43± 5.33
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| | Day 1 |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Two sample t-test comparing baseline and day 1 H0: There is no change in mean force between baseline and day 1 HA: There is change in mean force between baseline and day 1 | t-test, 2 sided | | 0.61 | | | | | | | | | | | | | | Superiority or Other | | | | Two sample t-test comparing baseline and day 2 H0: There is no change in mean force between baseline and day 2 HA: There is change in mean force between baseline and day 2 |
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| Secondary | Stability of Baseline Measurements of Force | The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge on three different days prior to injection of BoNT/A or placebo. On each of the three days of baseline testing, the force was defined as the mean of three different measurements, separated by at least 1 minute from another measurement. | Normal controls at baseline before BoNT/A injected | Posted | | Mean | Standard Deviation | kg | | Baseline 1 (mean of 3 measurement on the same day of testing) compared with Baseline 2 (mean of 3 measurement on the same day of testing) on a second day compared with Baseline 3 (mean of 3 measurement on the same day of testing) | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin Type A, 20 Units | Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle | | OG001 | Botulinum Toxin, Type A, 2 Units | Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle | | OG002 | Placebo |
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| Secondary | Difference in Force From Day 14 to Day 21 | The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A). The force at each day of testing was the mean of the 3 values for force obtained on that day. Value is percent change from baseline. Comparison is made between the percent change from baseline force and the force on Day 14 in each group vs. the percent change from baseline force and the force on Day 21 in each group. | | Posted | | Mean | Standard Deviation | percent change from baseline | | Force measured at Day 14 after BoNT/A injction into EDB and Force measured at Day 21 after BoNT/A injction into EDB. | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin Type A, 20 Units | Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle | | OG001 | Botulinum Toxin, Type A, 2 Units | Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle | | OG002 | Placebo | |
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| Secondary | Number of Participants With Serious Adverse Effects to onabotulinumtoxinA (Botulinum Type A Neurotoxin) | | | Posted | | Number | | participants | | At each visit for nerve conduction studies following injection of onabotulinumtoxinA (botulinum type A neurotoxin) into EDB (Day 0; Day 4; Day 14; Month 4) | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin Type A, 20 Units | Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle | | OG001 | Botulinum Toxin, Type A, 2 Units | Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle | | OG002 | Placebo | Saline, Single dose, Intramuscular injection into right EDB Saline: Single Dose, Intramuscular into right EDB muscle |
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| Secondary | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. | Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements. | Posted | | Mean | Standard Deviation | percent change from baseline | | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | | | | ID | Title | Description |
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| OG000 | CMAP (Standard) With Botulinum Toxin Type A, 20 Units | Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle |
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| Secondary | Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB. | Measure the percent change of the Surface Electromyogram (SEMG) as measured by the Mean Rectified Voltage (MRV) with a window of 500 ms from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A or placebo. Each MRV represents the mean of 3 individual measurements of the MRV at that timepoint with measurements at least 60 seconds apart. In order to facilitate comparison from one subject to the next, the MRV is then converted into percent change from baseline for that subject. | | Posted | | Mean | Standard Deviation | percent change from baseline | | Baseline (mean of 3 measurement on the same day of testing) then following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin Type A, 20 Units | Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle | | OG001 | Botulinum Toxin, Type A, 2 Units | Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle |
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| Secondary | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. | Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements. | Posted | | Mean | Standard Deviation | percent change from baseline | | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | | | | ID | Title | Description |
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| OG000 | CMAP (Standard) With Botulinum Toxin Type A, 20 Units | Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle |
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| Secondary | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. | Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements. | Posted | | Mean | Standard Deviation | percent change from baseline | | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | | | | ID | Title | Description |
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| OG000 | CMAP (Standard) With Botulinum Toxin Type A, 20 Units | Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle |
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| Secondary | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. | Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements. | Posted | | Mean | Standard Deviation | percent change from baseline | | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | | | | ID | Title | Description |
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| OG000 | CMAP (Standard) With Botulinum Toxin Type A, 20 Units | Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle |
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| Secondary | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. | Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements. | Posted | | Mean | Standard Deviation | percent change from baseline | | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | | | | ID | Title | Description |
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| OG000 | CMAP (Standard) With Botulinum Toxin Type A, 20 Units | Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle |
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| Secondary | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. | Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements. | Posted | | Mean | Standard Deviation | percent change from baseline | | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | | | | ID | Title | Description |
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| OG000 | CMAP (Standard) With Botulinum Toxin Type A, 20 Units | Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle |
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| Secondary | Correlation in Percent Change of the CMAP (With "Inactive" Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an "inactive" location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. | Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements. | Posted | | Mean | Standard Deviation | percent change from baseline | | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | | | | ID | Title | Description |
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| OG000 | CMAP ("Inactive") With Botulinum Toxin Type A, 20 Units | Compound muscle action potential (CMAP) with reference electrode in an "inactive" location at the ipsilateral medial malleolus Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle |
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| Secondary | Correlation in Percent Change of the CMAP (With "Inactive" Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an "inactive" location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. | Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements. | Posted | | Mean | Standard Deviation | percent change from baseline | | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | | | | ID | Title | Description |
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| OG000 | CMAP ("Inactive") With Botulinum Toxin Type A, 20 Units | Compound muscle action potential (CMAP) with reference electrode in an "inactive" location at the ipsilateral medial malleolus Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle |
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| Secondary | Correlation in Percent Change of the CMAP (With "Inactive" Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an "inactive" location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. | Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements. | Posted | | Mean | Standard Deviation | percent change from baseline | | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | | | | ID | Title | Description |
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| OG000 | CMAP ("Inactive") With Botulinum Toxin Type A, 20 Units | Compound muscle action potential (CMAP) with reference electrode in an "inactive" location at the ipsilateral medial malleolus Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle |
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| Secondary | Correlation in Percent Change of the CMAP (With "Inactive" Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an "inactive" location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. | Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements. | Posted | | Mean | Standard Deviation | percent change from baseline | | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | | | | ID | Title | Description |
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| OG000 | CMAP ("Inactive") With Botulinum Toxin Type A, 20 Units | Compound muscle action potential (CMAP) with reference electrode in an "inactive" location at the ipsilateral medial malleolus Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle |
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| Secondary | Correlation in Percent Change of the CMAP (With "Inactive" Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an "inactive" location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. | Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements. | Posted | | Mean | Standard Deviation | percent change from baseline | | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | | | | ID | Title | Description |
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| OG000 | CMAP ("Inactive") With Botulinum Toxin Type A, 20 Units | Compound muscle action potential (CMAP) with reference electrode in an "inactive" location at the ipsilateral medial malleolus Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle |
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| Secondary | Correlation in Percent Change of the CMAP (With "Inactive" Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an "inactive" location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. | Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements. | Posted | | Mean | Standard Deviation | percent change from baseline | | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | | | | ID | Title | Description |
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| OG000 | CMAP ("Inactive") With Botulinum Toxin Type A, 20 Units | Compound muscle action potential (CMAP) with reference electrode in an "inactive" location at the ipsilateral medial malleolus Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle |
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