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

Muscle Spasticity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575054
• Other study ID #: 191622-116
• Secondary ID: 2011-004980-63
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2012
• Last updated: December 29, 2015
• Start date: May 2012
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Research Ethics Medical CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: July 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Germany,  Hungary,  Korea, Republic of,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 and averaged at weeks 4 and 6 for analysis. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.	Baseline, 6 Weeks	No
Primary	Clinical Global Impression of Overall Change (CGI) 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. Scores are averaged at weeks 4 and 6. Higher scores indicate a greater improvement from baseline.	Baseline, 6 weeks	No