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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this feasibility study is to determine if temporary weakness of a small foot muscle caused by local injection of botulinum toxin into that muscle can be measured with a strain gauge in addition to the previously known valid measurements via nerve conduction studies and surface electromyogram.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Loma Linda University
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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.