Clinical trial NCT00465738: IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
Official title: Prospective, Randomized, Observer-blind, Parallel-group, Multi-center Trial to Assess Efficacy and Safety of Two Different Dilutions of incobotulinumtoxinA (Xeomin) in Patients With Upper Limb Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Upper Limb Spasticity
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2007-04-25
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 several months, and may improve an impaired muscle function by lessening the muscle tightness within few days. IncobotulinumtoxinA is widely used for various severe neurological conditions. There is some evidence that the treatment effect may be influenced by the amount of the solvent in which incobotulinumtoxinA is diluted before injection.

Eligibility 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

Primary outcomes:
measure: Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set
timeFrame: At week 4
Secondary outcomes:
measure: Responder in DAS at Week 4 - Full Analysis Set
timeFrame: week 4
measure: Responder in DAS at Week 12 - Full Analysis Set
timeFrame: week 12
measure: Responder in DAS at Follow up - Full Analysis Set
timeFrame: follow up visit, between week 12 and week 20
measure: Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set
timeFrame: Week 4
measure: Responder in FAT at Week 12 - Full Analysis Set
timeFrame: Week 12
measure: Responder in FAT at Follow up - Full Analysis Set
timeFrame: follow up visit, between week 12 and week 20
measure: Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set
timeFrame: week 4
measure: Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set
timeFrame: week 12
measure: Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set
timeFrame: follow up visit, between week 12 and week 20
measure: Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set
timeFrame: week 4
measure: Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set
timeFrame: week 12
measure: Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set
timeFrame: follow up visit, between week 12 and week 20
measure: Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set
timeFrame: week 4
measure: Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set
timeFrame: week 12
measure: Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set
timeFrame: follow up visit, between week 12 and week 20
measure: Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set
timeFrame: week 4
measure: Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set
timeFrame: week 12
measure: Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set
timeFrame: follow up visit, between week 12 and week 20
measure: Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set
timeFrame: week 4
measure: Responder in Ashworth Scale (Forearm Pronators) at Week 12 - Full Analysis Set
timeFrame: week 12
measure: Responder in Ashworth Scale (Forearm Pronators) at Follow up - Full Analysis Set
timeFrame: follow up visit, between week 12 and week 20
measure: Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension
timeFrame: baseline, week 4, week 12, follow up (between week 12 and week 20)
measure: Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension
timeFrame: baseline, week 4, week 12, follow up (between week 12 and week 20)
measure: Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion
timeFrame: baseline, week 4, week 12, follow up (between week 12 and week 20)
measure: Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion
timeFrame: baseline, week 4, week 12, follow up (between week 12 and week 20)
measure: Investigator's Global Assessment of Treatment Response (GATR) - Full Analysis Set
timeFrame: week 4
measure: Patient's Global Assessment of Treatment Response (GATR) - Full Analysis Set
timeFrame: week 4
measure: Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Feeding
timeFrame: week 4
measure: Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Feeding
timeFrame: week 12
measure: Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Feeding
timeFrame: follow up visit, between week 12 and week 20
measure: Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Grooming
timeFrame: week 4
measure: Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Grooming
timeFrame: week 12
measure: Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Grooming
timeFrame: follow up visit, between week 12 and week 20
measure: Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Toilet Use
timeFrame: week 4
measure: Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Toilet Use
timeFrame: week 12
measure: Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Toilet Use
timeFrame: follow up visit, between week 12 and week 20
measure: Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Bathing/Showering
timeFrame: week 4
measure: Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Bathing/Showering
timeFrame: week 12
measure: Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Bathing/Showering
timeFrame: follow up visit, between week 12 and week 20
measure: Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Dressing
timeFrame: week 4
measure: Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Dressing
timeFrame: week 12
measure: Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing
timeFrame: follow up visit, between week 12 and week 20
Other outcomes:
Locations:
city: Hermagor
country: Austria
city: Innsbruck
country: Austria
city: Vienna
country: Austria
city: Besancon
country: France
city: Garches
country: France
city: Lille
country: France
city: Paris
country: France
city: Beelitz-Heilstaetten
country: Germany
city: Duesseldorf
country: Germany
city: Gladbeck
country: Germany
city: Bari
country: Italy
city: Costa Masnaga
country: Italy
city: Messina
country: Italy
city: Mestre
country: Italy
city: Milano
country: Italy
city: Rome
country: Italy
city: Lisbon
country: Portugal
city: Tocha
country: Portugal
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Terrassa
country: Spain
city: Bern
country: Switzerland
city: Nottwil
country: Switzerland
city: Kent
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Wakefield
country: United Kingdom
Study officials:
affiliation: Hunters Moor Hospital, Newcastle-upon-Tyne, UK
name: Michael P Barnes, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: