Overview

This trial is active, not recruiting.

Condition muscle spasticity
Treatments botulinum toxin type a, normal saline
Phase phase 3
Sponsor Allergan
Start date April 2012
End date September 2014
Trial size 468 participants
Trial identifier NCT01575054, 191622-116, 2011-004980-63

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Double-Blind Study Phase: 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.
botulinum toxin type a BOTOX®
Double-Blind Study Phase: 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)
Double-Blind Study Phase: 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.
botulinum toxin type a BOTOX®
Double-Blind Study Phase: 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.
normal saline
Double-Blind Study Phase: 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 Outcomes

Measure
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
Clinical Global Impression of Overall Change (CGI) by Physician Using a 9-Point Scale
time frame: Baseline, 6 Weeks

Secondary Outcomes

Measure
Goal Attainment Score Using a 6-Point Scale
time frame: Week 8, Week 12
Change from Baseline in MAS-B Score of Optional Muscles Using a 6-Point Scale
time frame: Baseline, 12 Weeks
Change from Baseline in Pain Score Using an 11-Point Scale
time frame: Baseline, 12 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Allergan.