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

This study is currently recruiting participants.
Verified November 2013 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01575054
First received: April 9, 2012
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Muscle Spasticity
Biological: botulinum toxin Type A
Drug: Normal Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Overall Change (CGI) by Physician Using a 9-Point Scale [ Time Frame: Baseline, 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Goal Attainment Score Using a 6-Point Scale [ Time Frame: Week 8, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in MAS-B Score of Optional Muscles Using a 6-Point Scale [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Pain Score Using an 11-Point Scale [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 418
Study Start Date: April 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: botulinum toxin Type A
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.
Biological: botulinum toxin Type A
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 Names:
  • BOTOX®
  • onabotulinumtoxin A
Normal Saline (Placebo) Followed by botulinum toxin Type A
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.
Biological: botulinum toxin Type A
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 Names:
  • BOTOX®
  • onabotulinumtoxin A
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575054

Contacts
Contact: Allergan, Inc clinicaltrials@allergan.com

Locations
United States, California
Recruiting
Downey, California, United States
United States, Florida
Recruiting
Daytona Beach, Florida, United States
Canada, Quebec
Recruiting
Montreal, Quebec, Canada
Czech Republic
Recruiting
Prague, Czech Republic
Germany
Recruiting
Wiesbaden, Germany
Recruiting
Würzburg, Germany
Hungary
Recruiting
Budapest, Hungary
Korea, Republic of
Recruiting
Gyeonggi-Do, Korea, Republic of
Poland
Recruiting
Krakow, Poland
Russian Federation
Recruiting
Krasnoyarsk, Russian Federation
United Kingdom
Recruiting
Stoke-on-Trent, England, United Kingdom
Recruiting
Fazakerley, Liverpool, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01575054     History of Changes
Other Study ID Numbers: 191622-116, 2011-004980-63
Study First Received: April 9, 2012
Last Updated: November 19, 2013
Health Authority: Hungary: Research Ethics Medical Committee
United States: Food and Drug Administration

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014