Back to resultsBOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity
Primary Purpose
Muscle Spasticity
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
botulinum toxin Type A
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Spasticity
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
botulinum toxin Type A
Normal Saline (Placebo) Followed by botulinum toxin Type A
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale
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
Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale
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.
Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS)
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.
Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale
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.
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01575054
Brief Title
BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
468 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin Type A
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal Saline (Placebo) Followed by botulinum toxin Type A
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A
Other Intervention Name(s)
BOTOX®, onabotulinumtoxin A
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale
Description
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.
Time Frame
Baseline, 6 Weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale
Description
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.
Time Frame
Baseline, 6 weeks
Title
Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS)
Description
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.
Time Frame
Week 8
Title
Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale
Description
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.
Time Frame
Baseline, Week 6
Title
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale
Description
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.
Time Frame
Baseline, Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Downey
State/Province
California
Country
United States
City
Daytona Beach
State/Province
Florida
Country
United States
City
Montreal
State/Province
Quebec
Country
Canada
City
Prague
Country
Czech Republic
City
Wiesbaden
Country
Germany
City
Würzburg
Country
Germany
City
Budapest
Country
Hungary
City
Gyeonggi-Do
Country
Korea, Republic of
City
Krakow
Country
Poland
City
Krasnoyarsk
Country
Russian Federation
City
Stoke-on-Trent
State/Province
England
Country
United Kingdom
City
Fazakerley
State/Province
Liverpool
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29330071
Citation
Wein T, Esquenazi A, Jost WH, Ward AB, Pan G, Dimitrova R. OnabotulinumtoxinA for the Treatment of Poststroke Distal Lower Limb Spasticity: A Randomized Trial. PM R. 2018 Jul;10(7):693-703. doi: 10.1016/j.pmrj.2017.12.006. Epub 2018 Jan 9.
Results Reference
derived
Learn more about this trial
BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity
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