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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
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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

Study Design
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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
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: BOTOX® 4 U/kg
Subjects will receive 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.
 Biological: botulinum toxin Type A
Subjects will receive intramuscular injections of botulinum toxin Type A 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb.
Other Name: BOTOX®
Experimental: BOTOX® 8 U/kg
Subjects will receive 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.
 Biological: botulinum toxin Type A
Subjects will receive intramuscular injections of botulinum toxin Type A 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb.
Other Name: BOTOX®
Placebo Comparator: Normal Saline (Placebo)
Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the lower limb.
 Drug: Normal Saline (Placebo)
Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the lower limb.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Modified Ashworth Scale - Bohannon (MAS-B) Ankle Score Using a 6-Point Scale [ Time Frame: Baseline, 6 Weeks ]
  2. Clinical Global Impression (CGI) Of Overall Change by Physician Compared to Baseline Using a 9-Point Scale [ Time Frame: Baseline, 6 Weeks ]

Secondary Outcome Measures :
  1. Goal Attainment Score as Assessed by Physician Using a 6-Point Scale [ Time Frame: Week 12 ]
  2. Change from Baseline in Severity of Spasticity of the Ankle Calculated Using the Modified Tardieu Scale (MTS) [ Time Frame: Baseline, 6 Weeks ]

Eligibility Criteria
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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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


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Sponsors and Collaborators
Allergan
Investigators
Study Director: Rozalina Dimitrova Allergan
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR‐CTRegistration@Allergan.com for assistance.  This link exits the ClinicalTrials.gov site

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01603628     History of Changes
Other Study ID Numbers: 191622-111
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017

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