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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT01392300
First received: July 7, 2011
Last updated: March 19, 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 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:


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
Study Completion Date: February 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
Merz Investigational Site #001184
Downey, California, United States, 90242
Merz Investigational Site #001017
Fountain Valley, California, United States, 92728
United States, Florida
Merz Investigational Site #001188
Miami, Florida, United States, 33172
United States, Georgia
Merz Investigational Site #001037
Augusta, Georgia, United States, 30912
United States, Illinois
Merz Investigational Site #001186
Chicago, Illinois, United States, 60611
United States, Kansas
Merz Investigational Site # 001110
Overland Park, Kansas, United States, 66211
United States, New Jersey
Merz Investigational Site #001198
Stratford, New Jersey, United States, 08084
United States, North Carolina
Merz Investigational Site #001240
Chapel Hill, North Carolina, United States, 27599
Merz Investigational Site #001009
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Merz Investigational Site #001241
Philadelphia, Pennsylvania, United States, 19140
Merz Investigational Site #001211
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Merz Investigational Site #001245
Chattanooga, Tennessee, United States, 37403
United States, Texas
Merz Investigational Site #001226
Houston, Texas, United States, 77030
Czech Republic
Merz Investigational Site #420046
Brno, Czech Republic, 62500
Merz Investigational Site #420029
Brno, Czech Republic, 65691
Merz Investigational Site #420028
Olomouc, Czech Republic, 77520
Merz Investigational Site #420024
Ostrava-Poruba, Czech Republic, 70852
Merz Investigational Site #420025
Pardubice, Czech Republic, 53203
Merz Investigational Site #420030
Praha, Czech Republic, 12000
Merz Investigational Site #420045
Praha, Czech Republic, 15006
Merz Investigational Site #420047
Rychnov nad Kneznou, Czech Republic, 51601
Germany
Merz Investigational Site #049134
Rostock, Germany, 18147
Hungary
Merz Investigational Site #036004
Budapest, Hungary, 1121
Merz Investigational Site # 036009
Budapest, Hungary, 1204
Merz Investigational Site #036005
Nyiregyhaza, Hungary, 4400
Merz Investigational Site #036008
Szeged, Hungary, 6725
India
Merz Investigational Site #091003
Porur, Chennai, India, 600116
Merz Investigational Site #091006
Bangalore, Karnataka, India, 560054
Merz Investigational Site #091002
Trivandrum, Kerala, India, 695011
Merz Investigational Site #091007
Chennai, Tamil Nadu, India, 600116
Merz Investigational Site #091008
Coimbatore, Tamil Nadu, India, 641014
Merz Investigational Site #091001
Lucknow, Uttar Pradesh, India, 226003
Merz Investigational Site #091004
New Delhi, India, 110065
Poland
Merz Investigational Site # 048029
Gdansk, Poland, 80-254
Merz Investigational Site #048044
Kielce, Poland, 25-103
Merz Investigational Site #048031
Krakow, Poland, 31-505
Merz Investigational Site #048050
Lodz, Poland, 90-130
Merz Investigational Site #048051
Lublin, Poland, 20-022
Merz Investigational Site #048032
Olsztyn, Poland, 10-561
Merz Investigational Site #048053
Poznan, Poland, 61-485
Merz Investigational Site #048023
Warszawa, Poland, 02-957
Merz Investigational Site #048033
Warszawa, Poland, 04-749
Merz Investigational Site #048052
Warszawa, Poland, 04-141
Russian Federation
Merz Investigational Site #007010
Krasnoyarsk, Russian Federation, 660037
Merz Investigational Site #007011
Moscow, Russian Federation, 105005
Merz Investigational Site #007009
St. Petersburg, Russian Federation, 129019
Merz Investigational Site #007005
Stavropol, Russian Federation, 355000
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: March 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014