Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg 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 leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

Condition	Intervention	Phase
Post-stroke Spasticity of the Lower 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, Caregiver, Investigator, Outcomes Assessor) 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 Lower 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) for plantar flexors at Week 4 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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).
Co-primary variable: Investigator's Global Assessment of Efficacy at Week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.

Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post markting commitments for U.S. regulatory authorities only. Elswhere, it will be a secondary outcome measure.

Secondary Outcome Measures:

Response rate for plantar flexors at all post-baseline visits for subjects with an improvement (reduction) of at least 1 point from baseline in the Ashworth Scale (AS) [ Time Frame: Week 4, 8, and 12 ] [ Designated as safety issue: No ]
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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).
Change from baseline in Ashworth Scale (AS) for plantar flexors at all post-baseline visits [ Time Frame: From baseline up to week 12 ] [ Designated as safety issue: No ]
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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.

Estimated Enrollment:	328
Study Start Date:	December 2011
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	October 2014 (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.
Placebo Comparator: Placebo Comparator Arm 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:

Age from 18-80 yrs
Lower 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 lower 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: NCT01464307

Contacts

Contact: Public Disclosure Manager

clinicaltrials@merz.de

Show 57 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:	NCT01464307 History of Changes
Other Study ID Numbers:	MRZ 60201/SP/3002, 2010-024579-23
Study First Received:	November 1, 2011
Last Updated:	April 17, 2013
Health Authority:	United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Canada: Health Canada Austria: Agency for Health and Food Safety Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: The Italian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Spain: Agencia Española de Medicamentos y Productos Sanitarios

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 May 16, 2013

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