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

NCT ID: NCT01575054

Last Updated: 2016-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-07-31

Brief Summary

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

Conditions

Muscle Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

botulinum toxin Type A

Intervention Type: BIOLOGICAL

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.

Normal Saline (Placebo) Followed by botulinum toxin Type A

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.

Group Type: OTHER

botulinum toxin Type A

Intervention Type: BIOLOGICAL

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.

Normal Saline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: DRUG

Other Intervention Names

BOTOX®; onabotulinumtoxin A

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Downey, California, United States

Daytona Beach, Florida, United States

Montreal, Quebec, Canada

Prague, , Czechia

Wiesbaden, , Germany

Würzburg, , Germany

Budapest, , Hungary

Krakow, , Poland

Krasnoyarsk, , Russia

Gyeonggi-do, , South Korea

Stoke-on-Trent, England, United Kingdom

Fazakerley, Liverpool, United Kingdom

Countries

United States; Canada; Czechia; Germany; Hungary; Poland; Russia; South Korea; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 29330071 (View on PubMed)

Other Identifiers

2011-004980-63

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

191622-116

Identifier Type: -

Identifier Source: org_study_id