IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity

NCT00465738 | Completed Phase 3 Results

• 1 other identifier: MRZ 60201 - 0607 / 1
• Study Type: interventional
• Target: 216
• Locations: 8 countries
• Sites: 27

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 (Xeomin).

Conditions

Upper Limb Spasticity

Outcome Measures

Primary Outcomes (1)

• Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set

  The primary efficacy endpoint is the number of responder at Week 4; response defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit to Week 4. The DAS determines the functional impairment for the domains hygiene, dressing, limb position and pain according to the following scale: 0 = no disability; 1 = mild disability; 2 = moderate disability; 3 = severe disability. At Screening visit, the subject and investigator, selected together one of the four domains as the primary therapeutic target.

  At week 4

Secondary Outcomes (42)

• Responder in DAS at Week 4 - Full Analysis Set

  week 4

• Responder in DAS at Week 12 - Full Analysis Set

  week 12

• Responder in DAS at Follow up - Full Analysis Set

  follow up visit, between week 12 and week 20

• Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set

  Week 4

• Responder in FAT at Week 12 - Full Analysis Set

  Week 12

Study Arms (2)

incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL

EXPERIMENTAL

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.

Drug: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")

incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL

ACTIVE COMPARATOR

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.

Drug: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")

Interventions

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") DRUG

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 or 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Dilution with 2.0 or 5.0 mL resulted in a dose of 50 or 20 units per 1.0 mL.

Also known as: incobotulinumtoxinA, Xeomin, NT 201, Botulinum toxin type A (150 kD), free from complexing proteins

incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL; incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (27)

Unknown Facility

Hermagor, Austria

Location

Unknown Facility

Innsbruck, Austria

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Besançon, France

Location

Unknown Facility

Garches, France

Location

Unknown Facility

Lille, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Beelitz-Heilstätten, Germany

Location

Unknown Facility

Düsseldorf, Germany

Location

Unknown Facility

Gladbeck, Germany

Location

Unknown Facility

Bari, Italy

Location

Unknown Facility

Costa Masnaga, Italy

Location

Unknown Facility

Messina, Italy

Location

Unknown Facility

Mestre, Italy

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Rome, Italy

Location

Unknown Facility

Lisbon, Portugal

Location

Unknown Facility

Tocha, Portugal

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Terrassa, Spain

Location

Unknown Facility

Bern, Switzerland

Location

Unknown Facility

Nottwil, Switzerland

Location

Unknown Facility

Kent, United Kingdom

Location

Unknown Facility

Liverpool, United Kingdom

Location

Unknown Facility

Plymouth, United Kingdom

Location

Unknown Facility

Wakefield, United Kingdom

Location

MeSH Terms

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Claus Goebel, MD
• Organization: Merz Pharmaceuticals GmbH

claus.goebel@merz.de

+49-69-1503-6461

Study Officials

• Michael P Barnes, MD, FRCP

  Hunters Moor Hospital, Newcastle-upon-Tyne, UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 24, 2007
• First Posted: April 25, 2007
• Study Start: February 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 31, 2010
• Results First Posted: December 6, 2010

Record last verified: 2010-12

Locations

IT (6); DE (3); CH (2); ES (3); PT (2); GB (4); FR (4); AU (3)