IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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 (Xeomin).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merz Pharmaceuticals GmbH
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Main Inclusion Criteria:

• 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 Criteria:

• 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