At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 27 enrolled
Drug / intervention
incabotulinumtoxinA +1 morebiological
Likely dose
incabotulinumtoxinA 200 unitsfrom 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.
A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Incobotulinumtoxin Type A for the Functional Improvement of Lower Extremity Spasticity in Patients With Multiple Sclerosis
Multiple Sclerosis Center of Northeastern New York·interventional·Posted Oct 24, 2013·Updated Mar 22, 2017
In Brief
A Phase 4 clinical trial evaluating incabotulinumtoxinA and Placebo for Muscle Spasticity and Multiple Sclerosis. Completed, enrolled 27 participants across 1 site.
Detailed Summary
The purpose of this study is to determine if Xeomin® will prove effective for significantly improving lower extremity spasticity and will be well tolerated by the majority of MS patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMuscle Spasticity, Multiple Sclerosis
CountriesUnited States
CollaboratorsMerz North America, Inc.
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 2013
Enrollment StartNov 2013
Primary CompletionJan 2016
Study CompletionDec 2016
TodayJul 2026
First PostedOct 24, 2013
Enrollment StartNov 1, 2013
Primary CompletionJan 27, 2016
Study CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.7 years ago
Interventions
incabotulinumtoxinAbiological
A dose of 200 units to 400 units of Xeomin will be injected by EMG-guided technique into the appropriate muscles in the effected leg at injection visit
Placebobiological
Saline injection on the day of injection visit