Upper Limb SpasticityPhase 3NT-SpinNCT00465738
IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
A Phase 3 study testing incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") in people with Upper Limb Spasticity, run by Merz Pharmaceuticals GmbH at 27 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Spasticity
- What is being tested?
- incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 27 sitesin 8 countries
- Study dates
- Feb 2007to May 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
27 sites in 8 countries.
27 sites in 8 countries
Italy6 sites
Study site
Bari
Study site
Costa Masnaga
Study site
Messina
Study site
Mestre
Study site
Milan
Study site
Rome
France4 sites
Study site
Besançon
Study site
Garches
Study site
Lille
Study site
Paris
United Kingdom4 sites
Study site
Kent
Study site
Liverpool
Study site
Plymouth
Study site
Wakefield
Germany3 sites
Study site
Beelitz-Heilstätten
Study site
Düsseldorf
Study site
Gladbeck
About this study
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
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).
Read the 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.
- Conditions
- Upper Limb Spasticity
- Being tested
- incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")Drug
Also called incobotulinumtoxinA, Xeomin, NT 201, 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At week 4
Secondary outcomes (42)
Responder in DAS at Week 4 - Full Analysis Set
Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.
Measured: week 4
Responder in DAS at Week 12 - Full Analysis Set
Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.
Measured: week 12
Responder in DAS at Follow up - Full Analysis Set
Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.
Measured: follow up visit, between week 12 and week 20
Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set
Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.
Measured: Week 4
Responder in FAT at Week 12 - Full Analysis Set
Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.
Measured: Week 12
Responder in FAT at Follow up - Full Analysis Set
Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.
Measured: follow up visit, between week 12 and week 20
Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. The Ashworth Scale is a 5-point-scale to rate to degree of spasticity: 0 = No increase in tone; 1 = Slight increase in tone giving a "catch" when the limb was moved in flexion or extension; 2 = More marked increase in tone, but limb easily flexed; 3 = Considerable increase in tone - passive movements difficult; 4 = Limb rigid in flexion or extension.
Measured: week 4
Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: week 12
Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: follow up visit, between week 12 and week 20
Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: week 4
Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: week 12
Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: follow up visit, between week 12 and week 20
Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: week 4
Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: week 12
Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: follow up visit, between week 12 and week 20
Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: week 4
Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: week 12
Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: follow up visit, between week 12 and week 20
Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: week 4
Responder in Ashworth Scale (Forearm Pronators) at Week 12 - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: week 12
Responder in Ashworth Scale (Forearm Pronators) at Follow up - Full Analysis Set
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Measured: follow up visit, between week 12 and week 20
Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension
For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.
Measured: baseline, week 4, week 12, follow up (between week 12 and week 20)
Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension
For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.
Measured: baseline, week 4, week 12, follow up (between week 12 and week 20)
Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion
For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.
Measured: baseline, week 4, week 12, follow up (between week 12 and week 20)
Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion
For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.
Measured: baseline, week 4, week 12, follow up (between week 12 and week 20)
Investigator's Global Assessment of Treatment Response (GATR) - Full Analysis Set
The investigator's global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.
Measured: week 4
Patient's Global Assessment of Treatment Response (GATR) - Full Analysis Set
The patient's global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.
Measured: week 4
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Feeding
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: week 4
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Feeding
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: week 12
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Feeding
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: follow up visit, between week 12 and week 20
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Grooming
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: week 4
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Grooming
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: week 12
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Grooming
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: follow up visit, between week 12 and week 20
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Toilet Use
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: week 4
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Toilet Use
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: week 12
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Toilet Use
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: follow up visit, between week 12 and week 20
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Bathing/Showering
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: week 4
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Bathing/Showering
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: week 12
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Bathing/Showering
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: follow up visit, between week 12 and week 20
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Dressing
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: week 4
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Dressing
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: week 12
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
Measured: follow up visit, between week 12 and week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startFeb 2007
- Primary completionJan 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Limb SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael P Barnes, MD, FRCP, Principal investigator, Hunters Moor Hospital, Newcastle-upon-Tyne, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465738
- Sponsor's protocol ID
- MRZ 60201 - 0607 / 1
- Acronym
- NT-Spin
- Status last verified
- Dec 2010
- First submitted
- 24 Apr 2007
- Last updated
- 31 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00465738
- Acronym / sponsor ID
- NT-Spin / MRZ 60201 - 0607 / 1
- Conditions
- Upper Limb Spasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Apr 2007 (estimated)
- Results
- Posted 6 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | Experimental | Drug: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")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. |
| incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | Active comparator | Drug: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")Also: incobotulinumtoxinA, Xeomin, NT 201, Botulinum toxin type A (150 kD), free from complexing proteinsactive 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. | Drug | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL, incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL |
Primary outcome
Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set
Time frame: At week 4
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.
42 secondary outcomes
Responder in DAS at Week 4 - Full Analysis Set
Time frame: week 4
Responder in DAS at Week 12 - Full Analysis Set
Time frame: week 12
Responder in DAS at Follow up - Full Analysis Set
Time frame: follow up visit, between week 12 and week 20
Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set
Time frame: Week 4
Responder in FAT at Week 12 - Full Analysis Set
Time frame: Week 12
Responder in FAT at Follow up - Full Analysis Set
Time frame: follow up visit, between week 12 and week 20
Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set
Time frame: week 4
Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set
Time frame: week 12
Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set
Time frame: follow up visit, between week 12 and week 20
Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set
Time frame: week 4
Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set
Time frame: week 12
Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set
Time frame: follow up visit, between week 12 and week 20
Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set
Time frame: week 4
Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set
Time frame: week 12
Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set
Time frame: follow up visit, between week 12 and week 20
Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set
Time frame: week 4
Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set
Time frame: week 12
Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set
Time frame: follow up visit, between week 12 and week 20
Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set
Time frame: week 4
Responder in Ashworth Scale (Forearm Pronators) at Week 12 - Full Analysis Set
Time frame: week 12
Responder in Ashworth Scale (Forearm Pronators) at Follow up - Full Analysis Set
Time frame: follow up visit, between week 12 and week 20
Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension
Time frame: baseline, week 4, week 12, follow up (between week 12 and week 20)
Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension
Time frame: baseline, week 4, week 12, follow up (between week 12 and week 20)
Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion
Time frame: baseline, week 4, week 12, follow up (between week 12 and week 20)
Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion
Time frame: baseline, week 4, week 12, follow up (between week 12 and week 20)
Investigator's Global Assessment of Treatment Response (GATR) - Full Analysis Set
Time frame: week 4
Patient's Global Assessment of Treatment Response (GATR) - Full Analysis Set
Time frame: week 4
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Feeding
Time frame: week 4
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Feeding
Time frame: week 12
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Feeding
Time frame: follow up visit, between week 12 and week 20
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Grooming
Time frame: week 4
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Grooming
Time frame: week 12
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Grooming
Time frame: follow up visit, between week 12 and week 20
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Toilet Use
Time frame: week 4
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Toilet Use
Time frame: week 12
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Toilet Use
Time frame: follow up visit, between week 12 and week 20
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Bathing/Showering
Time frame: week 4
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Bathing/Showering
Time frame: week 12
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Bathing/Showering
Time frame: follow up visit, between week 12 and week 20
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Dressing
Time frame: week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Barnes, MD, FRCP principal investigator
Hunters Moor Hospital, Newcastle-upon-Tyne, UK
27 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") in people with Upper Limb Spasticity, run by Merz Pharmaceuticals GmbH at 27 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy, France, United Kingdom, Austria, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set (time frame: At week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2010.