This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
235
Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.
Intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1.
Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at 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.
Time frame: Baseline (Day 1) to Weeks 4 and 6
Average Clinical Global Impression (CGI) of Overall Change by Physician at 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.
Time frame: Weeks 4 and 6
Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at 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.
Time frame: Baseline (Day 1) to Weeks 4 and 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AMS Neurology
Pasadena, California, United States
Harrison Clinical Management
Pomona, California, United States
Children's Hospital Colorado Dept. of PM&R
Aurora, Colorado, United States
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States
Axcess Medical Research, LLC
Loxahatchee Groves, Florida, United States
Pediatric Neurology, PA
Orlando, Florida, United States
Children's Healthcare of Atlanta Children's Rehabilitation Associates
Atlanta, Georgia, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
...and 35 more locations
Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale
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.
Time frame: Week 8 and 12
Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
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.
Time frame: Baseline (Day 1) to Week 6