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BOTOX® Treatment in Pediatric Lower Limb Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01603628
Recruitment Status : Completed
First Posted : May 22, 2012
Results First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE May 21, 2012
First Posted Date  ICMJE May 22, 2012
Results First Submitted Date  ICMJE June 12, 2018
Results First Posted Date  ICMJE August 14, 2018
Last Update Posted Date August 14, 2018
Actual Study Start Date  ICMJE September 11, 2012
Actual Primary Completion Date June 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6 [ Time Frame: Baseline (Day 1) to Weeks 4 and 6 ]
    The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the principal muscle group (elbow and wrist) by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis. A negative change from Baseline indicates improvement.
  • Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6 [ Time Frame: Weeks 4 and 6 ]
    The CGI of overall change (improvement or worsening) was assessed by the physician considering the participant's clinical condition and severity of side effects using a 9-point scale where: -4=very marked worsening to +4=very marked improvement. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2012)
  • Change from Baseline in Modified Ashworth Scale - Bohannon (MAS-B) Ankle Score Using a 6-Point Scale [ Time Frame: Baseline, 6 Weeks ]
  • Clinical Global Impression (CGI) Of Overall Change by Physician Compared to Baseline Using a 9-Point Scale [ Time Frame: Baseline, 6 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale [ Time Frame: Weeks 8 and 12 ]
    Two functional goals, one active and one passive, were selected by the participant and family in consultation with the physician investigator and/or treating physical therapist relative to the lower limb impairment due to spasticity. The physician assessed the achievement of the goals using a 6-point scale: where -3=worse than start to +2=much more than expected: improvements clearly exceed the defined therapeutic goal. An Analysis of Covariance (ANCOVA) model was used for analysis.
  • Change From Baseline in Severity of Spasticity of the Ankle With Knee Extended and Knee Flexed (R2-R1) Calculated Using the Modified Tardieu Scale (MTS) [ Time Frame: Baseline (Day 1) to Weeks 2, 4, 6, 8 and 12 ]
    The MTS measured the difference between slow and fast range of motion (R2-R1) and respective change from baseline to each posttreatment office visit. The MTS of the ankle was used to determine the passive range of movement at different movement velocities, V1 (as slow as possible) and V3 (as fast as possible) with the relative difference between a slow and fast velocity passive stretch determining the dynamic component of the muscle contracture for the joint. The investigator measured 2 joint angles by goniometer: the R1 angle which is the angle of catch after a fast velocity (V3) stretch and the R2 angle defined as the passive joint range of movement following a slow velocity (V1) stretch. The R2-R1 value indicated the level of the dynamic component of spasticity in the joint. The difference between R2 and R1 range of motion and respective change from baseline to each posttreatment office visit on the MTS was derived. An Analysis of Covariance (ANCOVA) model was used for analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2012)
  • Goal Attainment Score as Assessed by Physician Using a 6-Point Scale [ Time Frame: Week 12 ]
  • Change from Baseline in Severity of Spasticity of the Ankle Calculated Using the Modified Tardieu Scale (MTS) [ Time Frame: Baseline, 6 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BOTOX® Treatment in Pediatric Lower Limb Spasticity
Official Title  ICMJE BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study
Brief Summary This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pediatrics
  • Muscle Spasticity
  • Cerebral Palsy
Intervention  ICMJE
  • Biological: botulinum toxin Type A
    Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.
    Other Name: BOTOX®
  • Drug: Normal Saline (Placebo)
    Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.
Study Arms  ICMJE
  • Experimental: BOTOX® 4 U/kg
    Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).
    Intervention: Biological: botulinum toxin Type A
  • Experimental: BOTOX® 8 U/kg
    Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.
    Intervention: Biological: botulinum toxin Type A
  • Placebo Comparator: Normal Saline (Placebo)
    Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1. Participants received weekly PT.
    Intervention: Drug: Normal Saline (Placebo)
Publications * Not Provided

*   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
Actual Enrollment  ICMJE
 (submitted: September 1, 2017)
384
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2012)
412
Actual Study Completion Date  ICMJE June 28, 2017
Actual Primary Completion Date June 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Minimum weight of 10 kg/22 lb
  • Cerebral palsy with dynamic muscle contracture /spasticity of the ankle

Exclusion Criteria:

  • Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease
  • Uncontrolled epilepsy
  • Botulinum Toxin therapy of any serotype for any condition within the last 6 months
  • History of surgical intervention of the lower study leg or planned surgery of any limb during the study
  • Previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected upper limb during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Italy,   Korea, Republic of,   Philippines,   Poland,   Russian Federation,   Thailand,   Turkey,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT01603628
Other Study ID Numbers  ICMJE 191622-111
2012-000042-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rozalina Dimitrova Allergan
PRS Account Allergan
Verification Date July 2018

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