Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke - Full Text View

Purpose

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.

Condition	Intervention	Phase
Post-stroke Spasticity of the Upper Limb.	Drug: IncobotulinumtoxinA (400 Units) Drug: Placebo Comparator	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: OnabotulinumtoxinA

U.S. FDA Resources

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:

Change from baseline in Ashworth Scale (AS) Score of primary target clinical pattern [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Primary target clinical pattern is defined by investigator for each subject at baseline visit and will be 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). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Investigator's Global Impression of Change [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
This is a 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 Outcome Measures:

Response rates in each treated muscle group (elbow, wrist, and finger flexors as well as thumb muscles and forearm pronators) at all post-baseline visits for subjects with an improvement (=reduction) of at least 1 point from baseline measured by the AS. [ Time Frame: Baseline up to week 48 ] [ Designated as safety issue: No ]
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).
Changes from baseline to all post-baseline visits in Ashworth Scale Score for each treated muscle group. [ Time Frame: Baseline up to week 48 ] [ Designated as safety issue: No ]
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).
Changes from baseline to all post-baseline visits in Disability Assessment Scale (primary therapeutic target and additionally all 4 items regardless of chosen primary therapeutic target) [ Time Frame: Baseline up to week 48 ] [ Designated as safety issue: No ]
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Response rates for the primary target clinical pattern for subjects with an improvement (=reduction) of at least 1 point from baseline measured by the Ashworth Scale [ Time Frame: Baseline up to week 48 ] [ Designated as safety issue: No ]
Primary target clinical pattern is defined by investigator for each subject at baseline visit and will be either flexed wrist or clenched fist or flexed elbow.

Enrollment:	317
Study Start Date:	September 2011
Estimated Study Completion Date:	March 2014
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: IncobotulinumtoxinA (Xeomin) (400 Units) 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.	Drug: IncobotulinumtoxinA (400 Units) Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection Other Name: Xeomin
Placebo Comparator: Placebo Comparator Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.	Drug: Placebo Comparator Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392300

Show 47 Study Locations

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

Investigators

Study Director:

Medical Expert

Merz Pharmaceuticals GmbH

More Information

No publications provided

Responsible Party:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT01392300 History of Changes
Other Study ID Numbers:	MRZ 60201/SP/3001, 2010-023043-15
Study First Received:	July 7, 2011
Last Updated:	June 3, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Muscle Spasticity
Stroke
Cerebral Infarction
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke (PURE)