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

Completed · Phase 3 · Has a placebo group

Conditions studied: Muscle Spasticity

In brief

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

Key facts

Study ID

NCT01575054

Run by

Allergan

People needed

468

Starts

2012-05-01

Expected to finish

2015-07-01

Last updated by the study team

2016-09-28

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Downey, California, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Montreal, Quebec, Canada
• Study site — Prague, Czechia
• Study site — Wiesbaden, Germany
• Study site — Würzburg, Germany
• Study site — Budapest, Hungary
• Study site — Krakow, Poland
• Study site — Krasnoyarsk, Russia
• Study site — Gyeonggi-do, South Korea
• Study site — Stoke-on-Trent, England, United Kingdom
• Study site — Fazakerley, Liverpool, United Kingdom

Full record on ClinicalTrials.gov

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