At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Botulinum Type B +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis Associated Symptomatic Sweating, or Residual Limb Hyperhidrosis in Amputees
Henry M. Jackson Foundation for the Advancement of Military Medicine·interventional·Posted Aug 24, 2012·Updated Jan 10, 2013
In Brief
A Phase 1 clinical trial evaluating Botulinum Type B and Placebo for Hyperhidrosis. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperhidrosis
CountriesUnited States
CollaboratorsWalter Reed National Military Medical Center
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedAug 2012
Primary CompletionDec 2012
TodayJul 2026
First PostedAug 24, 2012
Enrollment StartSep 1, 2008
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.9 years ago
Interventions
Botulinum Type Bdrug
Placebodrug