Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to determine if Myobloc significantly decreases prosthesis-associated symptomatic sweating in amputees when compared to a saline solution placebo. The study is randomized, double-blind, placebo-controlled, crossover trial with a total enrollment of 32 amputee subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborator: Walter Reed National Military Medical Center
• Treatments: Botulinum Toxins; Botulinum Toxins, Type A; rimabotulinumtoxinB

Criteria

Inclusion Criteria:

• Male or female, 18-50 years of age, active duty or retired military

• Limb amputation (single or multiple:for lower extremity amputees, amputation at the ankle or above; for upper extremity amputees, amputation at the wrist or above)

• Clear history of excessive sweating in a residual limb that is interfering with prosthesis fitting and functioning. This will be defined as focal, visible sweating in the region of the residual limb with at least one of the following characteristics: impairs prosthesis fitting, impairs functioning with a limb prosthesis

• Negative urine pregnancy test prior to the administration of study medication (for females)

Exclusion Criteria:

• Age less than 18 or greater than 50

• Any medical condition that may put the participant at increased risk with exposure to Myobloc, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis/motor neuron disease, neuropathy, renal stones, or any other disorder that may interfere with neuromuscular function

• Females who are pregnant, breast feeding, or planning a pregnancy during the study, or who think they may be pregnant at the start of the study

• Known allergy or sensitivity to any of the components in the study medication

• Known sensitivity to human albumin or albumin transfusions

• Current or planned use of aminoglycosides

• Systemic medical conditions (such as thyroid disease, hypertension, bleeding disorders, diabetes, cancers, etc.) that are not currently medically managed or controlled

• Current or planned use of a myoelectric prostheses (for upper extremity amputees), as the potential for weakness caused by botulinum toxin could interfere with muscle contraction

• Concurrent participation in another investigational drug or device study, or participation in the 30 days immediately prior to study enrollment

• Any condition or situation, in the investigator's opinion, that may put the participant at significant risk, confound the study results, or interfere significantly with the participant's ability to participate in the study

• Any previous use of Myobloc, Dysport, or BOTOX