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BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity

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ClinicalTrials.gov Identifier: NCT01575054
Recruitment Status : Completed
First Posted : April 11, 2012
Results First Posted : February 1, 2016
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.

Condition or disease Intervention/treatment Phase
Muscle Spasticity Biological: botulinum toxin Type A Drug: Normal Saline Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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Arm Intervention/treatment
Experimental: botulinum toxin Type A
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
 Biological: botulinum toxin Type A
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
Other Names:
  • BOTOX®
  • onabotulinumtoxin A
Normal Saline (Placebo) Followed by botulinum toxin Type A
Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
 Biological: botulinum toxin Type A
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
Other Names:
  • BOTOX®
  • onabotulinumtoxin A

Drug: Normal Saline
Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale [ Time Frame: Baseline, 6 Weeks ]
    The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the ankle flexors by passively moving the ankle plantar flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. The average of the weeks 4 and 6 MAS-B ankle change from baseline is the primary end point. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.


Secondary Outcome Measures :
  1. Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale [ Time Frame: Baseline, 6 weeks ]
    The CGI is a 9-point scale evaluating change from baseline status by the Physician. Scores range from +4 (very marked improvement) to -4 (very marked worsening). The average of the weeks 4 and 6 CGI by Physician score is used as a secondary end point. Higher scores indicate a greater improvement from baseline.

  2. Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS) [ Time Frame: Week 8 ]
    The physician-assessed GAS is an individualized, goal-oriented 6-point scale used to track functional improvement toward active and passive goals. GAS scoring ranged from -3 to 2 (-3 = worse than start; 0 = expected goal/attained the defined therapeutic goal; 2 = much more than expected/improvements clearly exceeded the defined therapeutic goal). Active and Passive Goal scores are presented.

  3. Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale [ Time Frame: Baseline, Week 6 ]
    The patient is asked to select a number that best describes his/her pain while walking on an 11-point scale from 0 = "no pain" to 10 = "pain as bad as can be imagined". Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses.

  4. Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale [ Time Frame: Baseline, Week 6 ]
    The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the optional muscles by passively moving the muscles through their range of motion. Optional muscles treated include: Rectus Femoris, Flexor Digitorum Longus, Flexor Hallucis Longus, and Extensor Hallucis. The scores range from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of post-stroke lower limb spasticity for at least 3 months
  • Minimum body weight of 50 kg

  • Never treated with botulinum toxin of any serotype for any reason, or if previously treated with botulinum toxin of any serotype, if previously treated for spasticity in the affected lower limb, must have been administered

    • 20 weeks before Day 1, or if previously treated for any other indication must have been administered ≥12 weeks prior to Day 1

Exclusion Criteria:

  • Spasticity in the opposite leg that requires treatment
  • Casting of the study limb within 6 months or planned casting during the first 12 weeks of the study
  • Treatment modalities in the study limb including ultrasound, electrical nerve stimulation, electrical stimulation, acupuncture within 1 month of Day 1 or treatments planned during the study
  • Not able to perform 10 meter walking test independently with or without assistive device
  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575054


Locations
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United States, California
Downey, California, United States
United States, Florida
Daytona Beach, Florida, United States
Canada, Quebec
Montreal, Quebec, Canada
Czech Republic
Prague, Czech Republic
Germany
Wiesbaden, Germany
Würzburg, Germany
Hungary
Budapest, Hungary
Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Poland
Krakow, Poland
Russian Federation
Krasnoyarsk, Russian Federation
United Kingdom
Stoke-on-Trent, England, United Kingdom
Fazakerley, Liverpool, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01575054    
Other Study ID Numbers: 191622-116
2011-004980-63 ( EudraCT Number )
First Posted: April 11, 2012    Key Record Dates
Results First Posted: February 1, 2016
Last Update Posted: September 28, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
 abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents