BOTOX® Treatment in Pediatric Upper Limb Spasticity

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 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 Design

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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
Study Start Date :	July 12, 2012
Actual Primary Completion Date :	June 29, 2017
Actual Study Completion Date :	July 6, 2017

Arms and Interventions

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

Arm	Intervention/treatment
Experimental: BOTOX® 3 U/kg; Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U per kg of body weight (3 U/kg) into specified muscles of the upper limb.	Biological: botulinum toxin Type A; Subjects will receive intramuscular injections of botulinum toxin Type A 3 U per kg of body weight (3 U/kg) into specified muscles of the upper limb.; Other Name: BOTOX®
Experimental: BOTOX® 6 U/kg; Subjects will receive 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.	Biological: botulinum toxin Type A; Subjects will receive intramuscular injections of botulinum toxin Type A 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb.; Other Name: BOTOX®
Placebo Comparator: Placebo; Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the upper limb.	Drug: Normal Saline (Placebo); Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the upper limb.

Outcome Measures

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Primary Outcome Measures :

1. Change from Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group 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. Change from Baseline in MAS-B Score of the Finger Flexor Muscle Group Using a 6-Point Scale [ Time Frame: Baseline, 6 Weeks ]
2. Goal Attainment Score as Assessed by Physician Using a 6-Point Scale [ Time Frame: Week 12 ]
3. Change from Baseline in Severity of Spasticity of the Principal Muscle Group Calculated Using the Modified Tardieu Scale (MTS) [ Time Frame: Baseline, 6 Weeks ]

Eligibility Criteria

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

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

Contacts and Locations

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

  Show 60 Study Locations

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. 

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01603602 History of Changes
Other Study ID Numbers:	191622-101
First Posted:	May 22, 2012
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