Assessment of the Effect of Botulinum Toxin in Extensor Digitorum Brevis Via Strain Gauge and Nerve Conduction Studies

Inclusion Criteria

• Normal, healthy, male or female subjects, 18 to 54 years of age.
• Written informed consent has been obtained.
• Females with child-bearing potential have a negative urine pregnancy test and agree to use a reliable form of contraception during the study.
• Ability to follow study instructions and likely to complete all required visits.
• Written authorization for Use and Release of Health and Research Study Information has been obtained.

Exclusion Criteria

• Abnormality by focused history and examination including the presence of foot deformity.
• Abnormal (as determined by the investigator) screening nerve conduction studies of the lower limbs.
• Identification of anomalous innervation of right EDB via screening nerve conduction studies.
• The subject having a foot which does not adequately fit in the modified ankle-foot orthosis used with the strain gauge.
• The subject having a foot in which anatomic bone landmarks cannot be adequately identified.
• Body mass index (BMI) greater than 30.
• History of significant (as determined by the investigator) lower limb injury or lower limb surgery
• Any uncontrolled clinically significant medical condition.
• Known allergy or sensitivity to any of the components in the study medication.
• Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
• Concurrent participation in another investigational drug or device study or participation within 3 months prior to study.
• Treatment with botulinum toxin of any serotype prior to enrollment in study or prior clinical botulism.
• Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
• Evidence of alcohol abuse, drug abuse, or other relevant neuropsychiatric condition.
• Infection or skin disorder at an anticipated injection site.
• Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results (e.g. variable strength on serial testing during screening examination; or foot, toe, or ankle pain that may limit full participation in muscle strength testing), or interfere significantly with the subject's participation in the study.