Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb

Merz Pharmaceuticals GmbH47 sites in 7 countries317 target enrollmentSeptember 2011

ConditionsPost-stroke Spasticity of the Upper Limb

InterventionsIncobotulinumtoxinA (400 Units)Placebo Comparator

DrugsIncobotulinumtoxinA (400 Units)Placebo Comparator

Overview

Phase: Phase 3
Intervention: IncobotulinumtoxinA (400 Units)
Conditions: Post-stroke Spasticity of the Upper Limb
Sponsor: Merz Pharmaceuticals GmbH
Enrollment: 317
Locations: 47
Primary Endpoint: Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.

Detailed Description

The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

February 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merz Pharmaceuticals GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Upper limb spasticity
•Time since stroke greater than 3 months
•Need for 400 U Botulinum toxin type A

Exclusion Criteria

•Body weight below 50kg
•Fixed contractures of the upper limb
•Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin Type A
•Infection at the injection site

Arms & Interventions

DB IncobotulinumtoxinA (Xeomin) (400 U)

IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment

Intervention: IncobotulinumtoxinA (400 Units)

DB Placebo Comparator

Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment

Intervention: Placebo Comparator

Outcomes

Primary Outcomes

Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern

Time Frame: Week 4

Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize 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).

Investigator's Global Impression of Change

Time Frame: Week 4

This is the co-primary outcome measure. The Global Impression of Change Scale \[GICS\] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.

Secondary Outcomes

Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow(Week 4)
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow(Week 8)
Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern(Week 4)
Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern(Week 8)
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist(Week 8)
Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern(Week 12)
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist(Week 12)
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.(Week 4)
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist(Week 4)
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow(Week 12)
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist(Week 4)
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist(Week 8)
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist(Week 12)
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm(Week 4)
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm(Week 8)
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm(Week 12)
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm(Week 4)
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm(Week 8)
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm(Week 12)
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.(Week 4)
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.(Week 8)
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.(Week 8)
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.(Week 12)
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.(Week 4)
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.(Week 8)
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.(Week 12)
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.(Week 4)
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.(Week 8)
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.(Week 12)
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.(Week 12)
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.(Week 4)
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.(Week 8)
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.(Week 12)
Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain(Week 4)
Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain(Week 8)
Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain(Week 12)
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene(Week 4)
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene(Week 8)
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene(Week 12)
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing(Week 4)
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing(Week 8)
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing(Week 12)
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position(Week 4)
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position(Week 8)
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position(Week 12)
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain(Week 4)
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain(Week 8)
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain(Week 12)