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Trial record 1 of 1 for:    NCT01603628
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BOTOX® Treatment in Pediatric Lower Limb Spasticity

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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

Brief Summary:
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.

Condition or disease Intervention/treatment Phase
Pediatrics Muscle Spasticity Cerebral Palsy Biological: botulinum toxin Type A Drug: Normal Saline (Placebo) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study
Actual Study Start Date : September 11, 2012
Actual Primary Completion Date : June 28, 2017
Actual Study Completion Date : June 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
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).
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®

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.
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®

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.
Drug: Normal Saline (Placebo)
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603628


Locations
Show Show 53 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Rozalina Dimitrova Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Statistical Analysis Plan  [PDF] August 16, 2017
Study Protocol  [PDF] July 25, 2016

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01603628    
Other Study ID Numbers: 191622-111
2012-000042-35 ( EudraCT Number )
First Posted: May 22, 2012    Key Record Dates
Results First Posted: August 14, 2018
Last Update Posted: August 14, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Muscle Spasticity
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents