Clinical trial NCT01575054: BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Muscle Spasticity
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-04-11
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb 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

Primary outcomes:
measure: Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale
timeFrame: Baseline, 6 Weeks
Secondary outcomes:
measure: Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale
timeFrame: Baseline, 6 weeks
measure: Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS)
timeFrame: Week 8
measure: Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale
timeFrame: Baseline, Week 6
measure: Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Downey
country: United States
state: California
city: Daytona Beach
country: United States
state: Florida
city: Montreal
country: Canada
state: Quebec
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
country: United Kingdom
state: England
city: Fazakerley
country: United Kingdom
state: Liverpool
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
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.