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

Allergan

Status and phase: Completed; Phase 3

Conditions: Muscle Spasticity

Treatments: Drug: Normal Saline; Biological: botulinum toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01575054

2011-004980-63 (EudraCT Number)

191622-116

Details and patient eligibility

About

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

Enrollment: 468 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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468 participants in 2 patient groups

botulinum toxin Type A

Experimental group

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.

Treatment:

Biological: botulinum toxin Type A

Normal Saline (Placebo) Followed by botulinum toxin Type A

Other group

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.

Treatment:

Drug: Normal Saline

Biological: botulinum toxin Type A