IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity

Sponsor
Merz Pharmaceuticals GmbH
Study ID
NCT00465738
Phase
PHASE3
Status
Completed

Conditions

  • Upper Limb Spasticity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Feb 28, 2007
Status verified
Dec 2010
Primary completion
Jan 31, 2008
Completion
May 31, 2008

Study Design

Enrollment
216 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
    incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Dilution with 5.0 mL resulted in a dose of 20 units per 1.0 mL.
  • Active Comparator: incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
    incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 mL sterile of NaCl 0.9% solution without preservatives. Dilution with 2.0 mL resulted in a dose of 50 units per 1.0 mL.

Primary Outcome Measure

Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set [ Time Frame: At week 4 ]