IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb

NCT00432666 | Completed Phase 3 Results

• 1 other identifier: MRZ 60201-0410
• Study Type: interventional
• Target: 148
• Locations: 3 countries
• Sites: 3

Brief Summary

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing proteins, i.e. free from proteins other than the active toxin. Injected into the muscle, incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for treatment of various neurological conditions. This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the upper limb.

Conditions

Post-stroke Upper Limb Spasticity

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors

  The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.

  Baseline, Week 4

Secondary Outcomes (77)

• Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors

  Baseline, Week 4

• Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits

  Baseline, Week 2, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

• Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits

  Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

• Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits

  Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

• Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits

  Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)

Other Outcomes (1)

• Onset of Treatment Effect [Classified]

  Period starting at baseline injection of the Main Period up to onset of treatment effect

Study Arms (2)

IncobotulinumtoxinA (Xeomin)

EXPERIMENTAL

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection

Drug: IncobotulinumtoxinA (Xeomin)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IncobotulinumtoxinA (Xeomin) DRUG

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection

IncobotulinumtoxinA (Xeomin)

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male patients ≥ 18 years
• ≥ 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g., neurologist)
• Focal spasticity with ≥ 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist
• Focal spasticity with ≥ 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist
• For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for Flexed Wrist and Clenched Fist
• For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 50 Units BOTOX® or 200 Units Dysport® or 2000 Units Neurobloc® (type B preparation) per each of these flexors: carpi ulnaris, digitorum superficialis, digitorum profundus
• For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 60 Units BOTOX® or 240 Units Dysport® or 2400 Units Neurobloc® (type B preparation) for flexor carpi radialis

You may not qualify if:

• Spasticity of any other origin than stroke
• Previous treatment with Botulinum Toxin of any serotype and for any body region within the 4 months prior to Screening (Visit 1, Day -7)
• Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region
• Previous or planned treatment with phenol- or alcohol-injection in the target limb
• Previous surgical treatment of spasticity in the target muscle(s)
• Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch
• Severe atrophy of the target limb muscles

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (3)

Unknown Facility

Czech Republic, Czechia

Location

Unknown Facility

Hungary, Hungary

Location

Unknown Facility

Poland, Poland

Location

MeSH Terms

Interventions

incobotulinumtoxinA

Results Point of Contact

• Title: Angelika Hanschmann
• Organization: Merz Pharmaceuticals GmbH

angelika.hanschmann@merz.de

++49-69-1503

Study Officials

• Merz Pharmaceuticals

  Merz Pharmaceuticals GmbH

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 7, 2007
• First Posted: February 8, 2007
• Study Start: June 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: May 1, 2008
• Last Updated: December 15, 2010
• Results First Posted: September 28, 2010

Record last verified: 2010-11

Locations

HU (1); PL (1); CZ (1)