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BOTOX® Treatment in Pediatric Upper Limb Spasticity

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ClinicalTrials.gov Identifier: NCT01603602
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 upper limb spasticity.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BOTOX® Treatment in Pediatric Upper Limb Spasticity: Double-blind Study
Actual Study Start Date : July 12, 2012
Actual Primary Completion Date : June 29, 2017
Actual Study Completion Date : July 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: BOTOX® 3 U/kg
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 units (U) per kilogram (kg) of body weight (3 U/kg) into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
Biological: botulinum toxin Type A
Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA

Experimental: BOTOX® 6 U/kg
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
Biological: botulinum toxin Type A
Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA

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




Primary Outcome Measures :
  1. Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group 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 MMRM model was used for analysis.


Secondary Outcome Measures :
  1. Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group 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 finger flexor muscle group 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. An Analysis of Covariance (ANCOVA) model was used for analysis. A negative change from Baseline indicates improvement.

  2. Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale [ Time Frame: Week 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 ANCOVA model was used for analysis.

  3. Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS) [ Time Frame: Baseline (Day 1) to Week 6 ]
    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 a fast velocity passive stretch determining the dynamic component of the muscle contracture for the joint. At each visit, 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 slow (R2) and fast (R1) range of motion and respective change from baseline to each posttreatment office visit on the MTS was derived.



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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
  • Upper limb spasticity due to cerebral palsy or stroke

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
  • Previous surgical treatment of the study limb (except tendon lengthening), or planned surgery of the study 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 lower 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): NCT01603602


  Show 45 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Rozalina Dimitrova Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] July 22, 2016
Statistical Analysis Plan  [PDF] September 11, 2017


Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01603602     History of Changes
Other Study ID Numbers: 191622-101
2012-000062-38 ( 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:
Cerebral Palsy
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
onabotulinumtoxinA
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