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

This study is currently recruiting participants.
Verified March 2014 by Merz Pharmaceuticals GmbH
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT01464307
First received: November 1, 2011
Last updated: March 18, 2014
Last verified: March 2014
  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:


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

  Hide Study Locations
Locations
United States, California
Merz Investigational Site #001184 Recruiting
Downey, California, United States, 90242
Merz Investigational Site #001208 Recruiting
Long Beach, California, United States, 90806
United States, Connecticut
Merz Investigational Site #001244 Recruiting
Fairfield, Connecticut, United States, 06824
United States, Kansas
Merz Investigational Site # 001110 Recruiting
Overland Park, Kansas, United States, 66211
United States, Maryland
Merz Investigational Site #001210 Recruiting
St. Louis, Maryland, United States, 63110
United States, Missouri
Merz Investigational Site #001209 Recruiting
Columbia, Missouri, United States, 65212
United States, New Jersey
Merz Investigational Site #001198 Recruiting
Stratford, New Jersey, United States, 08084
United States, New York
Merz Investigational Site #001207 Recruiting
Plainview, New York, United States, 11803
United States, North Carolina
Merz Investigational Site #001009 Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
Merz Investigational Site #001206 Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Merz Investigational Site #001183 Recruiting
Houston, Texas, United States, 77030
Austria
Merz Investigational Site #043003 Withdrawn
Wien, Austria, 1090
Canada, Nova Scotia
Merz Investigational Site #001204 Recruiting
Halifax, Nova Scotia, Canada, B3H 4K4
Canada, Quebec
Merz Investigational Site #001201 Withdrawn
Greenfield Park, Quebec, Canada, J4V 2H1
Canada
Merz Investigational Site #001202 Recruiting
Winnipeg, Canada, MB R3A 1M4
Czech Republic
Merz Investigational Site #420029 Withdrawn
Brno, Czech Republic, 65691
Merz Investigational Site #420028 Withdrawn
Olomouc, Czech Republic, 77520
Merz Investigational Site #420024 Recruiting
Ostrava-Poruba, Czech Republic, 70852
Merz Investigational Site #420031 Recruiting
Ostrava-Vitkovice, Czech Republic, 70384
Merz Investigational Site #420030 Recruiting
Praha, Czech Republic, 12000
Merz Investigational Site #420047 Recruiting
Rychnov nad Kneznou, Czech Republic, 51601
France
Merz Investigational Site #033018 Recruiting
Garches, France, 92380
Merz Investigational Site #033046 Withdrawn
Lille, France, 59037
Merz Investigational Site #033024 Recruiting
Rennes, France, 35043
Germany
Merz Investigational Site #049022 Recruiting
Beelitz-Heilstätten, Germany, 14547
Merz Investigational Site #049127 Withdrawn
Berlin, Germany, 13353
Merz Investigational Site #049071 Recruiting
Düsseldorf, Germany, 40225
Merz Investigational Site #049079 Recruiting
Hamburg, Germany, 20246
Merz Investigational Site #049304 Recruiting
Kiel, Germany, 24105
Merz Investigational Site #049072 Recruiting
München, Germany, 80804
Merz Investigational Site #049148 Recruiting
München, Germany, 81675
Merz Investigational Site #049303 Recruiting
Regensburg, Germany, 93053
Merz Investigational Site #049302 Recruiting
Würzburg, Germany, 97080
Italy
Merz Investigational Site #039006 Recruiting
Messina, Italy, 98125
Merz Investigational Site #039012 Recruiting
Roma, Italy, 00189
Merz Investigational Site #039011 Recruiting
Roma, Italy, 00168
Poland
Merz Investigational Site #048057 Recruiting
Gdansk, Poland, 80-462
Merz Investigational Site #048054 Recruiting
Krakow, Poland, 30-510
Merz Investigational Site #048031 Recruiting
Krakow, Poland, 31-505
Merz Investigational Site #048022 Recruiting
Lodz, Poland, 90-130
Merz Investigational Site #048051 Recruiting
Lublin, Poland, 20-022
Merz Investigational Site #048032 Withdrawn
Olsztyn, Poland, 10-561
Merz Investigational Site #048053 Recruiting
Poznan, Poland, 61-485
Merz Investigational Site #048055 Recruiting
Warszawa, Poland, 01-697
Merz Investigational Site #048056 Recruiting
Warszawa, Poland, 02097
Merz Investigational Site #048033 Recruiting
Warszawa, Poland, 04-749
Merz Investigational Site #048052 Withdrawn
Warszawa, Poland, 00-909
Merz Investigational Site #048023 Recruiting
Warszawa, Poland, 02-957
Russian Federation
Merz Investigational Site #007010 Recruiting
Krasnoyarsk, Russian Federation, 660037
Merz Investigational Site #007011 Recruiting
Moscow, Russian Federation, 105005
Merz Investigational Site #007009 Recruiting
St. Petersburg, Russian Federation, 129019
Merz Investigational Site #007012 Recruiting
Stavropol, Russian Federation, 355000
Spain
Merz Investigational Site #034027 Recruiting
Madrid, Spain, 28040
Merz Investigational Site #034028 Recruiting
Majadahonda, Spain, 28222
Merz Investigational Site #034026 Recruiting
Sevilla, Spain, 41009
Merz Investigational Site #034030 Recruiting
Sevilla, Spain, 41013
Merz Investigational Site #034029 Recruiting
Terrassa, Spain, 08221
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: March 18, 2014
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 April 15, 2014