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

NCT01575054 | Completed Phase 3 Results

• 2 other identifiers: 191622-1162011-004980-63
• Study Type: interventional
• Target: 468
• Locations: 9 countries
• Sites: 12

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

Outcome Measures

Primary Outcomes (1)

• 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. The average of the weeks 4 and 6 MAS-B ankle change from baseline is the primary end point. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

  Baseline, 6 Weeks

Secondary Outcomes (4)

• Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale

  Baseline, 6 weeks

• Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS)

  Week 8

• Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale

  Baseline, Week 6

• Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale

  Baseline, Week 6

Study Arms (2)

botulinum toxin Type A

EXPERIMENTAL

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.

Biological: botulinum toxin Type A

Normal Saline (Placebo) Followed by botulinum toxin Type A

OTHER

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.

Biological: botulinum toxin Type A; Drug: Normal Saline

Interventions

botulinum toxin Type A 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.

Also known as: BOTOX®, onabotulinumtoxin A

Normal Saline (Placebo) Followed by botulinum toxin Type A; botulinum toxin Type A

Normal Saline 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.

Normal Saline (Placebo) Followed by botulinum toxin Type A

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (12)

Unknown Facility

Downey, California, United States

Location

Unknown Facility

Daytona Beach, Florida, United States

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Wiesbaden, Germany

Location

Unknown Facility

Würzburg, Germany

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Krasnoyarsk, Russia

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Stoke-on-Trent, England, United Kingdom

Location

Unknown Facility

Fazakerley, Liverpool, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29330071 DERIVED

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2012
• First Posted: April 11, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: July 1, 2015
• Last Updated: September 28, 2016
• Results First Posted: February 1, 2016

Record last verified: 2016-08

Locations

HU (1); PL (1); CZ (1); RU (1); GB (2); US (2); KR (1); CA (1); DE (2)