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BOTOX® Versus Zanaflex® for the Treatment of Post-Stroke or Traumatic Brain Injury Upper Limb Spasticity

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ClinicalTrials.gov Identifier: NCT00430196
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : February 1, 2007
Sponsor:
Collaborator:
Allergan
Information provided by:
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE January 30, 2007
First Posted Date  ICMJE February 1, 2007
Last Update Posted Date February 1, 2007
Study Start Date  ICMJE December 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
wrist Modified Ashworth Score
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
  • Disability Assessment Scale
  • Modified Frenchay Assessment
  • Walking Speed
  • Contralateral Grip Strength
  • Contralateral Finger Tap
  • Epworth Sleepiness Scale
  • Cognitive Evaluations Questionnaire
  • Discontinuation
  • Titration schedule of oral study medication between treatment groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BOTOX® Versus Zanaflex® for the Treatment of Post-Stroke or Traumatic Brain Injury Upper Limb Spasticity
Official Title  ICMJE Placebo-Controlled Trial of BOTOX® Versus Zanaflex® for the Treatment of Subjects With Post Stroke Upper Limb Spasticity
Brief Summary

In this study, we will compare BOTOX® versus Zanaflex ® for the treatment of muscle overactivity in the upper limb following stroke or brain traums. This is a critical step in the development of local intramuscular treatment for patients with muscle overactivity following an acute brain lesions, as opposed to the more classic oral treatments.

This study will be a multicenter, randomized, prospective, parallel, double blind study that enrolls subjects at twelve sites (including Mt. Sinai) throughout the United States and Europe. The purpose of this study is to evaluate the safety and efficacy of BOTOX® compared to Zanaflex® in reducing upper limb muscle tone in post-stroke subjects, as well as evaluating changes in muscle tone-related disability and drug-therapy tolerance. This will be an 18 week study. Subjects are eligible if they have been medically stable with upper limb spasticity 6 months after their first stroke. Subjects will be randomized to one of three treatment groups: Treatment Group I - intramuscular BOTOX® plus oral placebo, Treatment Group II - intramuscular placebo plus oral Zanaflex®, Treatment Group III - intramuscular placebo plus oral placebo. The dose of BOTOX® will be at the discretion of the investigator with a maximum of 500 U per subject. The dose of the Zanaflex® will be 4mg/day to a maximum of 36mg/day. The study anticipates that 150 subjects will be enrolled to provide sufficient information to answer the primary objective of safety and efficacy of the study.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Upper Limb Spasticity
Intervention  ICMJE
  • Drug: BOTOX®
  • Drug: Zanaflex®
Study Arms  ICMJE Not Provided
Publications * Simpson DM, Gracies JM, Yablon SA, Barbano R, Brashear A; BoNT/TZD Study Team. Botulinum neurotoxin versus tizanidine in upper limb spasticity: a placebo-controlled study. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):380-5. doi: 10.1136/jnnp.2008.159657. Epub 2008 Oct 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 31, 2007)
135
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Outpatient, male and female subjects, of any race, between 18 and 85 years of age.
  • Female subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1/Screening. (A female is considered of childbearing potential unless she is postmenopausal or without a uterus and/or both ovaries.)
  • Subjects with a history of stroke or traumatic brain injury, more than 90 days prior to Visit 2/Baseline, that result in disability caused by focal upper limb muscle over activity, as assessed by the Investigator and characterized by the following:

    • A wrist Ashworth tone of +3 or greater as measured on the Modified Ashworth Scale at Visit 1/Screening and Visit 2/Baseline;
    • A minimum measurement of +2 on the Disability Assessment Scale (DAS) for the principal therapeutic intervention target assessment (hygiene, dressing, pain, and cosmesis) chosen by the Investigator and the subject or subject’s caregiver at Visit 1/Screening and Visit 2/baseline.
  • Subjects, who, as assessed by the Investigator, clearly understand the intent of the study and are willing and able to comply with study instructions, complete the entire study and sign Informed Consent Form.

Exclusion Criteria:

  • Female subjects who are pregnant (positive urine pregnancy test at Visit 1/screening), nursing, planning a pregnancy during the study period or female subjects of childbearing potential who are not using a reliable means of contraception. Reliable means of contraception. Reliable methods of contraception are hormonal methods or intrauterine device in use at least 14 days before study drug administration.
  • Subjects with a severe contracture at the wrist (inability to passively move the joint more than 10 degrees) or a history of tendon transfer in the study limb.
  • Subjects who have had a cast of the study limb within two weeks of the Visit 1/Screening or are planning casting of the study limb during the study period.
  • Subjects with a diagnosis of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
  • Subjects with profound atrophy (as per the Investigator’s assessment) of the muscle in the target area(s) of injection.
  • Subjects with an infection at the injection site or systemic infection (in this case, postpone study entry until one week following recovery).
  • Subjects with diagnosed orthostatic hypotension or subjects that are taking alpha-2 adrenergic agonists (e.g. clonidine).
  • Subjects with impaired renal and/or hepatic function.
  • Subjects with a known allergy or sensitivity to the study medications or its components.
  • Subjects who are currently taking tizanidine or have taken tizandidine within 14 days prior to Visit 2/Baseline.
  • Subjects who have received previous botulinum toxin injection(s) of any serotype into the target limb within 4 months of Visit 2/Baseline.
  • Subjects who have received phenol or alcohol injections to the study limb.
  • Subjects who are currently taking oral gabaergic medications (baclofen, gabapentin, benzodiazepines) or dantrolone sodium, or have been taking these drugs within 2 weeks of baseline (Visit 2). Please note that benzodiazepines will be excluded only as antispasmodic medications but not as hypnotics or anxiolytics on a PRN basis.
  • Subjects who have not been on stable doses of their CNS medications (antidepressant, antianxiety drugs) for at least 2 months prior to Visit 1 (dose regimen must remain stable throughout the study).
  • Subjects who are currently using medication that are contraindicated with the concomitant use of BOTOX® or Zanaflex®.
  • Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of Visit 1/Screening.
  • Subjects that in the Investigator’s opinion have a concurrent condition that may put them at significant risk, may confound the study results, or may interfere significantly with the conduct of the study.
  • Subjects with a history of poor cooperation, non-compliance with medical treatment, or unreliability.
  • Subjects currently receiving anticoagulant therapy and who have an INR > 3.5
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00430196
Other Study ID Numbers  ICMJE GCO # 02-0510
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: David Simpson, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP