Status:
COMPLETED
IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Upper Limb Spasticity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxinA (Xeom...
Detailed Description
IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins. Injected into a muscle, incobotulinumtoxinA causes a reversible local weakening of the muscle for seve...
Eligibility Criteria
Inclusion
- Main
- Female or male patients ≥ 18 years
- Stable upper limb spasticity of diverse etiology
- Focal spasticity with equal or more than 2 points on the Ashworth scale in the wrist flexors
- Disability Assessment Scale (DAS) ≥ 2 points for primary therapeutic target at both screening and baseline visits
- Main
Exclusion
- Fixed contracture
- Bilateral upper limb paresis/paralysis
- Previous treatment with BoNT of any serotype and for any body region within the 4 months prior to screening
- Previous or planned treatment with phenol- or alcohol-injection in the target limb
- Other muscle hypertonia (e.g. rigidity)
- Diagnosis of myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the study
- Severe atrophy of the target limb muscles
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00465738
Start Date
February 1 2007
End Date
May 1 2008
Last Update
December 31 2010
Active Locations (27)
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1
Hermagor, Austria
2
Innsbruck, Austria
3
Vienna, Austria
4
Besançon, France