Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-assoc… (NCT01671800) | Clinical Trial Compass
CompletedPhase 1
Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating
United States20 participantsStarted 2008-09
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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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…
What they're measuring
1
Amount of sweating
Timeframe: one month after initial injection
Trial details
NCT IDNCT01671800
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine